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  (New) Reusable Devices Requiring New Validation Data

The June 9, 2017 Federal Register identifies reusable medical devices that require “validated instructions for use” and “validation data requirements” in premarket notifications, i.e., 510(k)s.

 

The requirement comes from the 21st Century Cures Act, Section 3059 Cleaning Instructions and Validation Data Requirement, which says that FDA shall identify and publish a list of reusable device types for which 510(k) submissions are required to include (A) instructions for use and (B) validation data regarding cleaning, disinfection, and sterilization.

 

The Federal Register notice cited above contains the list. In addition, FDA-CDRH update the final guidance document Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. Appendix E, updated on June 9, 2017, contains the list which includes about 40 product codes.

 

 

Article on Risk Based Inspections added to the Ombu Library

The FDA Reauthorization Act of 2017, FDARA, changed the basis for scheduling device inspection. The law has shifted from a calendar basis, once in every two years, to a risk-based schedule. The Ombu Library, in the FDA Information aisle, has an article that explains the change and describes the risk factors.

 

 

UDI Compliance Data Extended

In a June 2, 2017 letter, FDA extended the compliance dates for Class I and unclassified devices. The compliance date for labels (including date format) and submitting data to GUDID is extended from September 24, 2018 to September 24, 2020. In addition, the compliance dates for direct marking these devices moves from September 24, 2020 to September 24, 2022.

 

The letter is available at https://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM561575.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

 

 

Article on FD&CA Amendment for Accessories Added to the Ombu Library

The recently enacted FDARA, Public Law 115-52, (https://www.congress.gov/bill/115th-congress/house-bill/2430#) includes an amendment that covers medical device accessories. This law repeals and replaces the section on accessories in the 21st Century Cures Act. The Ombu Library contains a summary of the amendments.

NB Defers Clinical Evaluation

In June 2016, the EU published MEDDEV 2.7/1 Rev. 4 Clinical Evaluation: A Guide For Manufacturers And Notified Bodies Under Directives 93/42/EEC and 90/385/EEC. This new version, replacing Rev. 3, includes significant changes. The revision to Rev. 4 does not have an effective data, which has caused significant confusion. Some Notified Bodies expected immediate implementation of the guidance in the manufacturer’s technical file or design dossier. Others expected the manufacturer to develop a transition plan to meet the new requirements in Rev. 4.

 

TÜV SÜD extended its implementation timeline to allow manufacturers more time to ensure compliance. On May 5, 2017 the EU published the Medical Device Regulation with a transition period to May 25, 2020. During this time, TÜV SÜD intends to accept clinical evaluation to Rev. 3 or Rev. 4. From May 26, 2020, clinical evaluations must implement Rev. 4.

 

It is not clear if other Notified Bodies will follow this approach.

 

 

FDARA Signed into Law

On August 18, 2017 the President signed FDARA into law. The Act may be cited as the FDA Reauthorization Act of 2017.

 

For device manufacturers, Title II is Fees Relating to Devices. It sets the user fees for the next few years.

 

In addition, Title VII is entitled Device Inspection and Regulatory Improvements. The title has the following sections.

Sec. 701 Risk-based inspections for devices

Sec. 702 Improvements to inspections process for device establishments

Sec. 703 Reauthorization of inspection program

Sec. 704 Certificates to foreign governments for devices

Sec. 705 Facilitating international harmonization

Sec. 706 Fostering innovation in medical imaging

Sec. 707 Risk-based classification of accessories

Sec. 708 Device pilot projects

Sec. 709 Regulation of over-the-counter hearing aids

Sec. 710 Report on servicing of devices

Use of Symbols in Device Labeling

On June 15, 2016 FDA issued a final rule Use of Symbols in Labeling. The rule is effective from September 13, 2016. The rule allows symbols in medical device labeling without adjacent explanatory text, i.e., “stand-alone symbols” when:

·         A national or international standards development organization (SDO) developed the symbol

·         A standard authorizes the “standardized symbol” for stand-alone use

·         The manufacturer includes a symbols glossary in the labeling for the device

 

To support the rule, FDA published a new standards-recognition notice to modify the current list of recognized standards.

 

https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-13990.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

 

An FDA webpage provides information https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/DeviceLabeling/ucm555598.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

 

 

IMDRF Coding for Adverse Events

The IMDRF guidance document IMDRF/AE WG/N43FINAL:2017 Terminologies for Categorized Adverse Event Reporting (AER): Terms, Terminology structure, and Codes proposes a common system adverse event reporting.

 

The system uses four distinct sets of terminologies and their associated codes. In general, the codes have a hierarchal structure.

·         Medical Device Problem terms/codes

·         Cause investigation terms/codes

·         Patient problem terms/codes

·         Component terms/codes

 

IMDRF is still developing the system, but when complete it will allow consistent interchange of information between regulators.

 

The IMDRF website is www.imdrf.org.

 

 

eSubmitter Handles C&R Reports

Corrections and Removal Reporting

The Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) has developed an eSubmitter tool which enables program participants to voluntarily complete and submit medical device correction and removal information electronically as outlined by 21 CFR 806. Once packaged, the submission can be sent to CDRH through the FDA Electronic Submissions Gateway (ESG), an agency-wide entry point for all electronic submissions.

 

To prepare the report, open eSubmitter and click on “Create New Submission”. The New Submission Data Dialog box will appear. Scroll down to “CDRH: 806 Corrections and Removal Reporting” and highlight the line. Click next at the bottom of the dialog box, and start preparing the report.

 

In addition, CDRH Learn has a module on electronic submissions of Part 806 reports. Go to https://www.fda.gov/Training/CDRHLearn/default.htm and click on Postmarket Activities. In the Medical Device Recalls section look for the entry “Electronic Submission of 806 Reports of Corrections and Removals”.

 

 

Article on EU-MDR Transition Time Lines added to the Ombu Library

The Ombu Library, in the EU-MDR aisle, has an article, EU-MDR Transition Time Lines, that includes considerations from transition from the MDD and AIMD to the MDR. The article includes both diagrams and bullet points to summarize the plans.

UDI Extension for Soft Contact Lenses

Effective March 30, 2017, FDA is granting an extension for labelers of soft (hydrophilic) contact lenses to comply with the requirements of the Unique Device Identification (UDI) system. The extension states, “Therefore, pursuant to 21 CFR §801.55(d), FDA grants to labelers of the devices listed … an extension of the requirements to provide a unique device identifier (UDI) on the device label and packages, format dates on the device label according to 21 CFR §801.18, and submit data to the GUDID until one year after FDA 1) develops and fully integrates the Technical Solution into the GUDID production system, 2) provides any necessary updated technical specifications to affected labelers, and 3) notifies industry that the extension will expire, through emails to industry, communication via trade associations, and via the UDI website.”

 

The letter is available at https://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM550122.pdf

 

 

Article on the term

The Ombu Library, in the Medical Device Regulations aisle, has an article on the use of “FDA Approved”. In conjunction with a 510(k) device, it renders the device misbranded. There is a similar prohibition against the phrase “FDA Registered”.

GUDID adds New Fields

The GUDID database contains two new fields related to a previous device identifier, DI.

 

The fields are Previous DI Number and Issuing Agency. Previous DI Number means a “Device Identifier assigned to a version/model of a medical device prior to the assignment of a new/substitute device identifier to that same version or model, without any changes to the device itself, due to merger and acquisition activity.” The Issuing Agency in this case, is the name of Previous DI Issuing agency.

 

 

Article on Signatures, Initials, and Stamps added to the Ombu Library

The Ombu Library, in the Medical Device Regulations aisle, has an article that discusses signatures, initials, and stamps in QSR and their application to “handwritten signatures”. The article does not discuss the use of electronic signatures.

Warning Letter on Calibration Added

The Ombu Library has analysis and recommendations of a Warning Letter involving calibration under §820.72. In this Warning Letter, a company has an inadequate procedure for the control of IM&TE as well as a piece of equipment without calibration traceable national or international standards.

 

EU-MDR and IVDR Published

The European Union published the Medical Device Regulation, numbered as Regulation (EU) 2017/745, in the Official Journal on May 5, 2017.

 

You may download the final text, 175 pages, from

http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745&from=EN

 

The European Union published the In Vitro Diagnostic Regulation, numbered as Regulation (EU) 2017/746), in the Official Journal on May 5, 2017.

 

You may download the final text, 157 pages, from

http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0746&from=EN

 

 

FDA Publishes Proposed List of 510(k) Exempt Devices

On March 14, 2017, FDA published a list of about 1,000 devices that would be exempt from 510(k) notification.

 

Under the Food, Drug, and Cosmetics Act, FD&CA, FDA must classify devices into one of three regulatory classes: Class I, Class II, or Class III. FDA determines the classification by the amount of regulation necessary to provide a reasonable assurance of safety and effectiveness.

 

On December 13, 2016, the President signed the 21st Century Cures Act into law. The law amends the FD&CA and requires FDA to publish, within 90 days of enactment with a 60-day comment period, a Federal Register notice with a list of Class II devices that FDA determines do not require a 510(k) submission. FDA must update the list at least once every 5 years thereafter.

 

Within 210 days of enactment, FDA must publish a Federal Register notice with the final determination of the 510(k) requirement. For those devices, regulated industry will no longer have to invest time and resources in 510(k) notifications, including preparation of documents and data for submission to FDA, payment of user fees associated with 510(k) submissions, and responding to questions and requests for additional information from FDA during 510(k) review.

 

The Federal Register notice is available from https://www.gpo.gov/fdsys/pkg/FR-2017-03-14/pdf/2017-04938.pdf

 

The Docket Number is FDA–2017–N–1129. One can make comments to the docket at https://www.regulations.gov.

 

 

Article on MDSAP Purchasing Process Added to the Ombu Library

The Ombu Library, in the MDSAP aisle, has an article on the purchasing process audit tasks in the Medical Device Single Audit Program, MDSAP. It paraphrases the audit tasks, often identifying separate activates, identifies the related section in FDA QSR, identifies the related clauses in ISO 13485:2016, and shows where the activities link to other processes.

FDA Issues Final Guidance Document on Combination Products

In January 2017, FDA issued the final guidance document, UCM429304, Current Good Manufacturing Practice Requirements for Combination Products.

 

The introduction says that this final guidance document describes and explains the final rule on combination products in 21 CFR Part 4. Prior to the final rule, there were regulations in place for the things that go into combination products, but no regulation to explain their application to the combination. This final guidance document provides additional information on applying the approach in Part 4.

 

 

FDA Announces Faster Device Recall Information

FDA-CDRH announced that it is posting recall information earlier than it had before. In the prior approach, the manufacturer would initiate a correction or removal under Part 806, notify FDA, and FDA would classify the resulting recall. In the new approach, FDA adds the information to the database before the recall classification.

 

The URL for the search engine is https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?source=govdelivery&utm_medium=email&utm_source=govdelivery

 

The manufacturer still submits the Part 806 information to the District Recall Coordinator, who will ask whether the information is ready to post in the database. If the information is ready, FDA-CDRH will post it.

 

A note for a typical entry says, “A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated.”

 

 

Article on Human Resources in ISO 13485-2016 Added to the Ombu Library

The Ombu Library, in the ISO 13485:2016 aisle, includes an article on Human Resources in ISO 13485:2016. It describes the issues surrounding competency and training.

Article on ALARP v AFAP Added to the Ombu Library

The Ombu Library, in the Risk Management for Medical Devices aisle, has an article explaining the difference between ALARP and AFAP as used in EN ISO 14971:2012. The article explains that ALARP has two considerations, but AFAP eliminates one of them. It also explains how to determine if the residual risk uses the AFAP approach.

EU Parliament Approves MDR and IVDR

On Wednesday April 5, 2017, the European Parliament approved the new Medical Device Regulation, MDR, and the In Vitro Device Regulation, IVDR. They will be published in the Official Journal, probably in May. This starts a three-year transition for the MDR and a five-year transition for the IVDR.

 

Both regulations make significant changes to the regulatory requirements.

Warning Letter Related to Accessories Added

The Ombu Library has analysis and recommendations of a Warning Letter for failure to properly manage the regulatory requirements for an accessory. In this Warning Letter, a company marketed a parent device with some accessories. The Warning Letter asserts the accessories are devices covered by an existing classification regulation and product code. Moreover, they are outside the scope of the company 510(k) clearance.

ISO Revises the Technical Report on Biocompatibility and Risk Management

ISO/TR 15499:2016 Biological Evaluation of Medical Devices – Guidance on the Conduct of Biological Evaluation within a Risk Management Process replaces the 2012 version. This new version applies to biological evaluation of medical devices according to the requirements of ISO 10993-1:2009 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process.

 

One aspect of biological evaluation is to reduce the risk the risk of patient harm. The technical report bridges the gap to ISO 14971:2007 Medical Devices – Application of Risk Management to Medical Devices, explaining how these two standards work together.

Article on EU-MDR Risk Management System added to the Ombu Library

The Ombu Library, in the EU-MDR aisle, has an article, EU-MDR Risk Management System, that describes the MDR’s requirements for risk management. The Risk Management System, RMS, is part of the Quality Management System, QMS. It has specific requirements and a priority order for risk reduction. There are also specific requirements for the reduction or elimination of risks associated with use error.

Article on EU-MDR General Safety and Performance added to the Ombu Library

The Ombu Library, in the EU-MDR aisle, has an article, EU-MDR General Safety and Performance, that describes the requirements that apply to all devices. They are in Annex I, which has three chapters. The article briefly describes the role of harmonized standards and common specifications. It concludes with recommendations for the manufacturer to start working on the technical documentation.

Article on EU-MDR Classification and Conformity Assessment added to the Ombu Library

The Ombu Library, in the EU-MDR aisle, has an article, EU-MDR Classification and Conformity Assessment, that describes the rule based classification system and illustrates the conformity assessment paths available to the manufacturer.

Article on EU-MDR Person Responsible added to the Ombu Library

The Ombu Library, in the EU-MDR aisle, has an article, EU-MDR Person Responsible, that describes qualifications and responsibilities of the Person Responsible for Regulatory Compliance under the MDR. Larger companies must have a person on staff, but smaller companies may use a contractor. The article provides the dividing lines on business size. The article concludes with recommendations for the manufacturer to fill the role.

 

 

Biocompatability and Risk Management TR Published

On December 1, 2016, ISO issued ISO/TR 15499:2016 Biological Evaluation of Medical Devices — Guidance on the Conduct of Biological Evaluation within a Risk Management Process. This is second edition, replacing ISO/TR 15499:2016.

 

The technical applies to activities to meet the requirements of ISO 10993-1:2009, Biological Evaluation of Medical Devices — Part 1: Evaluation and Testing within a Risk Management Process

 

Biological evaluation is part of the risk management process. The technical report sets ISO 10993-1:2009 in the context of ISO 14971:2007. It provides method and concepts applicable to medical device development.

 

 

 

EU Council Adopts MDR

On March 7, 2017, the EU Council unanimously adopted the text of the proposed Medical Device Regulation (MDR) and In-vitro Diagnostic Device Regulation (IVDR). The next step is a vote by the European Parliament in April. If approved the Official Journal of the European Union will publish the regulations and the transition period will begin.

 

The regulations replace the current Medical Device Directive, Active Implantable Directive, and the In-vitro Diagnostic Directive. The MDR has a three-year transition period and the IVDR has a five-year transition period.

 

 

Article on EU-MDR Economic Operators added to the Ombu Library

The Ombu Library, in the EU-MDR aisle, has an article, EU-MDR Economic Operators, that defines the economic operators and lists some of the relationships to the manufacturer and to other economic operators in the manufacturer’s distribution chain. The article also includes recommendations for activities the manufacturer should be working on.

 

FDA-CDRH Issues Guidance on Postmarket Cybersecurity

On December 28, 2016, FDA-CDRH issued a final guidance document entitled Postmarket Management of Cybersecurity in Medical Devices.

 

The final guidance document provides a framework for manufacturers to monitor, identify, and address cybersecurity vulnerabilities and exploits. Addressing cybersecurity exploits may require modification of the device already shipped. This raises the issue of Part 803 Corrections and Removals. The guidance provides an exception to reporting.

 

 

Article on the MDIC Device Complaint Metric added to the Ombu Library

The Ombu Library, in the Understanding Metrics aisle, includes an article on complaint metrics described in MDIC report on device metrics. It explains the basic metric proposed as well as refinements suggested in an Appendix.

MDIC Device Quality Metrics Published

The Medical Device Innovation Consortium, MDIC, on August 1, 2016, published Medical Device Quality Metrics – Best Practices Document for Metrics Identified Across the Total Product Lifecycle. The document supports the FDA CDRH Office of Compliance Case for Quality initiative.

 

It recommends metrics in three broad areas: Pre-production, Production, and Post-production. In each area, it names the metrics and provides a formula for calculating its value. In addition, Appendix B provides an example of the complaint metric analysis with a risk profile.

 

The report is available from the MDIC resource center http://mdic.org/cfq/resource-center-for-sustained-quality

 

 

 

 

 

Article on EU-MDR Transition Time Lines added to the Ombu Library

The Ombu Library, in the EU-MDR aisle, has an article, EU-MDR Transition Time Lines, that describes some considerations as the EU works on approving and implementing the Medical Device Regulation. The article discusses the transition period, certificates, Notified Bodies, and risk management.

EU-MDR Final Draft Published

The European Council released the final text of the Medical Device Regulation (MDR) and scheduled the vote for March 7, 2017. If passed, the MDR will go to the European Parliament in April.

 

If both bodies approve, the Official Journal could publish the MDR in May 2017, and it would enter into force in either May or June. Because there is a three-year transition period for the MDR, it would apply in 2020.

 

You may download the final text, 566 pages, from http://data.consilium.europa.eu/doc/document/ST-10728-2016-INIT/en/pdf

 

 

Warning Letter on Corrective & Preventive Action Added

The Ombu Library has analysis of a Warning Letter for failure to implement a corrective action as required by §820.100(a)(5). In this Warning Letter, the company had a recall and designed a check for the problem. During the inspection, the FDA Investigator went to the production floor and observed that the operators were not performing the check.

Recognition List #46 - Human Factors

In an update to the list of recognized standards (Recognition List #46) FDA-CDRH provides changes to the recognition of international standards on human factors/usability engineering.

 

IEC 62366 Edition 1.1 2014-01 Consolidated Version Medical devices--Application of usability engineering to medical devices is in transition

 

IEC 62366-1 Edition 1.0 2015-02 Medical Devices--Part 1: Application of Usability Engineering to Medical Devices [Including CORRIGENDUM 1 (2016)] is withdrawn and replaced with a newer version including corrigendum

 

The full list is available at https://www.gpo.gov/fdsys/pkg/FR-2016-12-23/html/2016-31008.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

 

It includes a number of standards not mentioned above.

FDA-CDRH Issues Final Guidance Document on Accessories

On December 30, 2016, FDA-CDRH issued a final guidance document entitled Medical Device Accessories – Describing Accessories and Classification Pathway for new Accessory Types. On January 30, 2017, they updated it to correct “an imprecise statement regarding finished devices”.

 

In the US, the Food, Drug, and Cosmetics Act, FD&CA, defines a medical device, which includes “any component, part, or accessory”. Consequently, FDA regulates accessories as devices.

 

Traditionally, FDA classified accessory types in one of two ways:

·         Inclusion in the same classification as the parent device

·         Issuing a unique, separate classification regulation for the accessory

 

The guidance document introduces a policy to classify accessories based on two factors:

·         Is the article an accessory?

·         What are the risks of the accessory when used as intended with the parent device

 

The guidance document identifies three issues for classification:

·         New accessory types may be classified by the de novo process

·         Accessory types already classified may seek reclassification

·         Accessory types already classified may seek an exemption from 510(k) submission

 

 

FDA-CDRH Issues Final Guidance Document on Emerging Signals

On December 14, 2016, FDA-CDRH issued a final guidance document, UCM479248, Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”).

 

The guidance document describes the FDA-CDRH policy for notifying the public about medical device about medical device emerging signals. The guidance document describes and emerging signal as new information:

1) that supports a new causal association or a new aspect of a known association between a device and an adverse event or set of adverse events, and

 

2) for which the Agency has conducted an initial evaluation and determined that the information has the potential to impact patient management decisions and/or the known benefit-risk profile of the device.

 

Information that is unconfirmed, unreliable, or lacks sufficient strength of evidence is not an emerging signal.

 

The guidance document explains that the contents of an emerging signal public notification may vary depending on the type of information available and the specific benefits and risks of the impacted device(s). The public information should include:

·         a description of the device(s) to which the public notification applies;

 

·         a summary of the emerging signal, including the objective evidence on which the decision to issue a public notification is based;

 

·         information on the known benefits and risks of the device and its use.

 

 

Proposed Rule Submitting Labels Electronically

 

On October 17, 2016, FDA-CDRH issued a proposed rule on Electronic Submission of Labeling for Certain Home-Use Medical Devices

 

You may see the comments to the docket at https://www.regulations.gov. The Docket Number is FDA-2016-N-2491.

 

Under the proposed rule, which affects Part 807, medical device establishments listing devices labelled for home use would submit the device label and package insert in an electronic format to FDA. FDA plans to make this device labeling information available to the public through an FDA-managed or partner Internet Web site.

 

The electronic submission would cover Class II and Class III “home use devices” defined as a medical device labeled for use outside a professional health care facility. The proposed rule would allow voluntary electronic submission for Class I devices.

 

 

FDA-CDRH publishes draft guidance document on Disseminating Patient-Specific Information

On June 10, 2016, FDA-CDRH issued a draft guidance document, UCM505756, Dissemination of Patient-Specific Information from Devices by Device Manufacturers.

 

You may the comments to the docket at https://www.regulations.gov. The Docket Number is FDA-2016-D-1264.

 

In the introduction, the draft guidance, FDA points out that patients increasingly seek to play a role in their own healthcare. The draft guidance document is intended to clarify that manufacturers may share patient-specific information recorded, stored, processed, retrieved, and/or derived from a medical device with the patient who is either treated or diagnosed with that specific device.

 

 

Article on 510(k) Exemption Added to the Ombu Library

The Ombu Library, in the Medical Device Regulations aisle, has an article explaining some of the issues related to devices that are 510(k) exempt. The article provides a documentation strategy to help explain the manufacturer’s decision.

 

 

Warning Letter on Corrections and Removals Added

The Ombu Library has analysis of a Warning Letter for failure to report a correction or removal as required by §880.10. In this Warning Letter, the company had a problem with a probe, notified customers, and asked for probes. However, the company did not notify FDA that it had asked the returns.

 

 

FDA Issues Draft Guidance Regarding Interoperable Medical Devices

On January 26, 2016, FDA-CDRH+CBER published a draft guidance document, UCM482649, entitled Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices. The draft guidance document recognizes that electronic medical devices increasingly connected to other devices and to other technologies. It defines interoperability as the ability of two or more products, technologies, and systems to both exchange information and to use the information exchanged.

 

The guidance document has a section on Design Considerations for Interoperable Devices and a section with Recommendations for the Contents of Pre-market Submissions.

 

 

Article on Transition to ISO 13485 added to the Ombu Library

The Ombu Library, in the ISO 13485:2016 aisle, has an article that describes the transition schedules for QMS schedules. The article includes diagrams that illustrate the transition periods. This includes Health Canada’s transition from CMDCAS certificates to MDSAP certificates.

Article on MDSAP Documents added to the Ombu Library

The Ombu Library, in the MDSAP aisle, has an article that identifies three documents that are important to medical device manufactures who anticipate an audit under the Medical Device Single Audit Program, MDSAP. It identifies the FDA website with its links to the MDSAP documents and briefly describes the Audit Document and the Companion Document. In addition, it the GHTF document that describes the nonconformity grading system.

 

 

CDRH FY2017 Guidance Plan

FDA-CDRH announced its plans, see UCM529396, for guidance document development in Fiscal Year 2017 (October 1, 2016 to September 30, 2017). The plan compromises lists, the A-List and the B-List. Each list also has a final guidance and a draft guidance component. The A-List is the prioritized medical device guidance documents FDA-CDRH intends to publish in FY 2017. The B-List is the guidance documents FDA-CDRH intends to publish, resources permitting.

 

A-List

Final Guidance Topics

·         Postmarket Management of Cybersecurity in Medical Devices

·         Medical Device Accessories: Describing Accessories and Classification Pathway for New Accessory Types

·         Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices

·         Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions

·         Suggested Format for Developing and Responding to Deficiencies

·         Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics

·         Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS) - Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases

·         Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS) – Based In Vitro Diagnostics

·         Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers

·         Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

·         510(k) Third Party Review Program

·         New or revised procedural guidance documents for MDUFA IV implementation

 

Draft Guidance Topics

·         IDE Submission, Content, Organization, Interactions

·         Update to Section V Demonstrating Insignificant Risk of an Erroneous Result in the Recommendations: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices guidance

·         Dual 510(k) and CLIA Waiver

·         New or revised procedural guidance documents for MDUFA IV implementation

 

B-List

Final Guidance Topics

·         Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies

·         Medical Device Development Tools (MDDT)

·         FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions

·         Unique Device Identification: Direct Marking of Devices

·         Technical Considerations for Additive Manufactured Devices

 

Draft Guidance Topics

·         Standard Content and Format for Patient Labeling of Medical Devices

·         Standard Content and Format for Healthcare Provider Labeling of Medical Devices

·         Patient Matched Instrumentation for Orthopedic Devices

·         Utilizing Simulated Animal Transplant Models to Evaluate the Safety of Perfusion-based Organ Preservation Devices

·         Strategy to Assess the Credibility of Computational Modeling Studies

·         Related Replacement Reagent and Instrument Policy

·         Unique Device Identification System: Defining the Labeler

·         Considerations to Support a Claim of Electromagnetic Compatibility for Medical Electrical Equipment and Medical Electrical Systems

 

 

Article on State of the Art added to the Ombu Library

The Ombu Library, in the Risk Management for Medical Devices aisle, has an article that discusses “state of the art” in ISO 14971:2007. State of the art is an important concept since it helps set the device manufacturer’s policy for risk acceptability.

 

 

Guidance on 510(k) marked as sterile

On January 21, 2016, FDA-CDRH issued a guidance document, updated March 16, 2016, UCM 109897, entitled Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.

 

The guidance address the issue, as stated by FDA-CDRH, “In recent years, FDA has received an increasing number of 510(k)s for devices labeled as sterile that use sterilization methods other than the traditionally used methods”, i.e., novel sterilization methods.

 

A Novel Sterilization Method is a method that FDA has not reviewed and determined to be adequate to effectively sterilize the device for its intended use.

Examples: Vaporized peracetic acid, High intensity light or pulse light, Microwave radiation, Sound waves, and Ultraviolet light

 

Established Sterilization Methods fall into two categories:

Established Category A have a long history of safe and effective use

Examples: Dry heat, EO with devices in a fixed, rigid chamber, Moist heat or steam, and Radiation (e.g., gamma, electron beam)

 

Established Category B have available published information on development, validation, and routine control

Examples: Hydrogen peroxide (H2O2), Ozone (O3), and Flexible bag systems (e.g., EO in a flexible bag system, diffusion method, injection method)

 

 

Article on Naming Conventions for Standards added to the Ombu Library

The Ombu Library, in the Medical Device Regulations aisle, has an article that explains the numbering conventions for standards. The article shows how the nomenclature changes as regions and countries adopt international standards. In particular, it discusses the nomenclature differences for the international and EU medical device risk management standards.

 

 

FDA Issues Final Guidance on Emerging Signals

FDA-CDRH issued the final guidance document UCM479248 Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”) on December 14, 2016. The guidance describes the policy for public notification of emerging signals. An emerging signal, based on the guidance has two attributes:

·         It supports a new causal association or a new aspect of a known association between a device and an adverse event or set of adverse events, and

·         FDA has conducted an initial evaluation and determined that the information has the potential to impact patient management decisions and/or the known benefit-risk profile of the device

 

Information that is unconfirmed, unreliable, or lacks sufficient strength of evidence is not an emerging signal.

 

 

Warning Letter on Software Validation added to the Ombu Library

The Ombu Library has analysis and recommendations of a Warning Letter for failure to validate software used in the company’s QMS as required by §820.70(i). In this Warning Letter, a company developed software for documenting and monitoring nonconformances with customer complaints, suppliers, internal/external audits, CAPA, and internal facility defects. However, during an inspection the FDA Investigator uncovered that they had not conducted validation.

Article on Supply Chain Roles in ISO 13485:2016 added to the Ombu Library

The Ombu Library, in the ISO 13485:2016 aisle, includes an article on supply chain roles in ISO 13485:2016. It describes the requirement for a company to identify its roles in each regulatory jurisdiction, determine the requirements for each role, and incorporate them into the QMS. As an example, it points out that the definitions of the roles the EU’s MDR are not same as the ISO 13485:2016 definitions.

 

 

510(k) Change Guidance - Update

FDA-CDRH recently released two draft guidance documents related to making changes in 510(k) cleared devices. FDA had previously released a controversial draft, but Congress passed a law, FDASIA, instructing FDA to withdraw the guidance and meet other conditions.

 

The draft guidance documents are the result of a public meeting and comments to docket.

 

“Deciding When to Submit a 510(k) for a Change to an Existing Device,” is the more broad draft guidance, while “Deciding When to Submit a 510(k) for a Software Change to an Existing Device”, covers the more specific software changes.

 

The 21st Century Cures Act includes an additional provision. Section 3059(b) requires, “The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue final guidance regarding when a premarket notification under section 510(k) of the Federal Food, Drug, and Cosmetic Act (4 U.S.C. 360(k)) is required to be submitted for a modification or change to a legally marketed device. Such final guidance shall be issued not later than 1 year after the date on which the comment period closes for the draft guidance on such subject.”

 

 

 

 

Article on Initial Importers Added to the Ombu Library

The Ombu Library, in the Medical Device Regulations aisle, includes an article on Initial Importers of devices into the US. It provides an overview of the foreign manufacturer’s requirements and the obligations of the initial importer.

FDA Recognition of MDSAP Audit Reports

In a letter to industry, dated September 29, 2016, Dr. Carl Fischer, Director of the Office of Compliance at CDRH said that an MDSAP audit generates a standardized MDSAP Audit Report. The report template assures effective documentation to satisfy the reporting requirements of all participating regulatory authorities (including the U.S. FDA). The U.S. Food and Drug Administration (FDA) recognizes MDSAP audit reports as a substitute for FDA Establishment Inspection Reports (EIRs).

 

You can read the letter at http://www.fda.gov/downloads/MedicalDevices/InternationalPrograms/MDSAPPilot/UCM523315.pdf

 

 

Article on UDI in the MDR added to the Ombu Library

The Ombu Library, in the UDI aisle, includes an article on the UDI requirements in the, soon to be published, EU Medical Device Regulations. It provides an overview of the requirements, recognizing that many of the details will become available only during the implementation phase. There is also a companion document with the core data elements in the EU database.

Article on Production Equipment Added to the Ombu Library

The Ombu Library, in the Production Equipment aisle, includes an article on QSR requirements for production equipment. It describes the requirements and includes implementation information and areas for an internal quality audit to cover.

 

 

Article on Risk in ISO 13485:2016 added to the Ombu Library

The Ombu Library, in the ISO 13485:2016 aisle, includes an article on risk in ISO 13485:2016. It describes the concept of risk from the standard, identifies processes for which the process control is “proportionate to the risk”, and explains how standard process controls can satisfy the requirement.

 

 

Article on Critical Suppliers Added to the Ombu Library

The Ombu Library, in the Managing the Supply Chain aisle, includes an article on determining critical suppliers and implementing controls. The article uses definitions from GHTF guidance documents as well as essential design outputs from QSR to define critical products, critical services, and critical suppliers. It also offers recommendations on controls, monitoring, and re-evaluation.

FDA Delays Action on LDTs

On September 18, 2016, FDA announced that it would wait for the new administration before issuing the guidance documents to end enforcement discretion of laboratory developed tests (LDTs). LDTs are tests developed and conducted in a single laboratory. Historically, they were simple tests with little or no impact on public health. In recent years, they have become more complex and more widely used prompting FDA to bring them under regulatory control.

 

FDA announced, “FDA believes that patients and health care providers need accurate, reliable, and clinically valid tests to make good health care decisions—inaccurate or false test results can harm individual patients. We have been working to develop a new oversight policy for laboratory developed tests, one that balances patient protection with continued access and innovation, and realize just how important it is that we continue to work with stakeholders, our new Administration, and Congress to get our approach right. We plan to outline our view of an appropriate risk-based approach in the near future. It is our hope that such an approach will help guide continued discussions.”

FDA Issues Draft Guidance on Emerging Signals

On December 31, 2015, FDA-CDRH issued a draft guidance Public Notification of Emerging Postmarket Medical Device Signals. The draft guidance describes FDA’s policy for notifying the public about medical device “emerging signals”. An emerging signal is new information about a medical device used in clinical practice:

1) that the Agency is monitoring or analyzing

 

2) that has the potential to impact patient management decisions and/or alter the known benefit-risk profile of the device

 

3) that has not yet been fully validated or confirmed

 

4) for which the Agency does not yet have specific recommendations

 

The draft guidance is available at http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm479248.pdf

 

The draft guidance is open to public comment at www.regulations.gov

 

Enter the docket number FDA-2015-D-4803 and you will be able to read all of the public comments.

 

 

FDA Issues Final MDR Guidance

On November 8, 2016, FDA-CDRH issued the final guidance Medical Device Reporting for Manufacturers. This guidance replaces the draft issued on July 9, 2013. It supersedes “Medical Device Reporting for Manufacturers” dated March 1997.

 

The guidance document describes and explains the current regulation in Part 803 that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for device-related adverse events and certain malfunctions.

 

The guidance document is available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm359566.pdf

 

 

Warning latter on Equipment Maintenance Added

The Ombu Library, in the Warning Letter aisle, has analysis and recommendations of a Warning Letter involving equipment maintenance supplier evaluation and selection as required by §820.70(g)(1) and (g)(2). In this Warning Letter, a company established daily maintenance activities, but the people didn’t perform them.

Article on Design Changes and 510(k) Submissions added to the Library

The Ombu Library, in the Medical Device Regulations aisle, has an article explaining the relationship between design changes and 510(k) submissions. The article explains the basis for a new 510(k) and discusses the current guidance document as well as the two draft guidance documents from FDA–CDRH.

 

 

FDA Draft Guidance on Benefit-Risk for Enforcement

On June 16, 2016, FDA-CDRH published a draft guidance document entitled Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions. The draft guidance is available from FDA as UCM506679. In addition, FDA opened a docket, FDA-2016-D-1495, on www.regulations.gov.

 

The draft guidance provides a framework by which FDA would make decisions on compliance and enforcement then there might be issues of patient safety or device availability. The draft guidance builds on factors in the premarket review benefit-risk framework to help provide consistency across the total product life cycle.

 

The draft guidance describes the factors to assess benefits and risks as well as other factors to consider. It includes worked examples and provides worksheets to help perform the assessments.

 

 

Article on Out of Calibration Equipment added to the Ombu Library

The Ombu Library, in the Medical Device Regulations aisle, has an article on IM&TE found out-of-calibration. The article cites the requirements from QSR and ISO 13485:2016 and includes the Audit Task from the MDSAP Audit Model.

 

Updated Regulations on Custom Devices

On October 12, 2016, FDA issued a final rule on custom devices designed to implement provisions of the Food, Drug, & Cosmetic Act, FD&CA.

 

The rule makes the following changes:

 

§807.85 Exemption from premarket notification

(a) A custom device is exempt from premarket notification requirements of this subpart if the device is within the meaning of section 520(b) of the Federal Food, Drug, and Cosmetic Act.

 

§812.3 Definitions

(b) A custom device means a device within the meaning of section 520(b) of the Federal Food, Drug, and Cosmetic Act.

 

 

FD&CA §520(b) [21 USC 360j: General provisions respecting control of devices intended for human use] has the following general provisions.

 

A custom device:

(A) is created or modified in order to comply with the order of an individual physician or dentist (or any other specially qualified person designated under regulations promulgated by the Secretary after an opportunity for an oral hearing);

 

(B) in order to comply with an order described in subparagraph (A), necessarily deviates from an otherwise applicable performance standard under section 360d of this title or requirement under section 360e of this title;

 

(C) is not generally available in the United States in finished form through labeling or advertising by the manufacturer, importer, or distributor for commercial distribution;

 

(D) is designed to treat a unique pathology or physiological condition that no other device is domestically available to treat;

 

(E)

(i) is intended to meet the special needs of such physician or dentist (or other specially qualified person so designated) in the course of the professional practice of such physician or dentist (or other specially qualified person so designated); or

 

(ii) is intended for use by an individual patient named in such order of such physician or dentist (or other specially qualified person so designated);

 

(F) is assembled from components or manufactured and finished on a case-by-case basis to accommodate the unique needs of individuals described in clause (i) or (ii) of subparagraph (E); and

(G) may have common, standardized design characteristics, chemical and material compositions, and manufacturing processes as commercially distributed devices.

 

There are also limitations:

(A) such device is for the purpose of treating a sufficiently rare condition, such that conducting clinical investigations on such device would be impractical;

 

(B) production of such device under paragraph (1) is limited to no more than 5 units per year of a particular device type, provided that such replication otherwise complies with this section; and

 

(C) the manufacturer of such device notifies the Secretary on an annual basis, in a manner prescribed by the Secretary, of the manufacture of such device.

 

On September 24, 2014, FDA-CDRH issued the guidance document Custom Device Exemption.

 

 

Article on Person Responsible added to the Ombu Library

In the Ombu Library, in the EU Device Regulations aisle, there is an article that describes the Person Responsible for Regulatory Compliance. This is a new role in both the MDR and IVDR. There are exceptions for small business, also described in the article.

 

 

Article on Complaints and Reliability added to the Ombu Library

The Ombu Library, in the Medical Device Regulations aisle, there is an article that describes the role of reliability in complaints. QSR, ISO 13485:2003, and ISO 13485:2016 includes reliability in the definition, but none of defines or describes reliability. The article makes a recommendation on data analysis, uses a Warning Letter as an example, and explains how data analysis could have helped prevent the problem.

 

 

 

 

FDA Issues Postmarket Surveillance Guidance Document

On May 16, 2016, FDA-CDRH issued a final guidance document entitled Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act.

 

In the US, FDA may order a manufacturer of certain Class II and Class III devices to initiate a postmarket study. The devices subject to an order are:

·         Failure of the device would be reasonably likely to have a serious adverse health consequence

·         Expected to have significant use in pediatric populations

·         Intended to be implanted in the human body for more than one year

·         Intended to be a life-sustaining or life-supporting device used outside of a user facility

 

The Food, Drug, and Cosmetic Act, FD&CA, provides FDA the authorization in Section 522, so these are usually called 522 orders. The law is implement in the regulations in 21 CFR Part 822. The guidance document provides additional information about the regulation.

 

 

Warning Letter on Supplier Selection and Evaluation Added

The Ombu Library, in the Warning Letter aisle, has analysis and recommendations of a Warning Letter involving supplier evaluation and selection as required by §820.50(a). In this Warning Letter, a company purchased a service, but didn’t evaluate the contractor before selection.

Recognition List #44 - Biocompatability

In an update to the list of recognized standards (Recognition List #44) FDA-CDRH provides a list of standards related to biocompatibility. The full list is available at https://www.gpo.gov/fdsys/pkg/FR-2016-07-26/pdf/2016-17570.pdf

 

It includes a number of standards that are reaffirmed or changed in the scope of recognition. In addition, there are eleven new standards added to the recognition list.

Article on Complaints and Warranty Claims added to the Ombu Library

The Ombu Library, in the Medical Device Regulations aisle, explains the QSR requirements classifying warranty claims as complaints. The article analyzes the complaint definition to explain why warranty status does not matter. In addition, it illustrates the issues with excerpts from Warning Letters.

Article on Essential Design Outputs added to the Ombu Library

The Ombu Library, in the Medical Device Regulations aisle, explains the QSR requirements for essential design outputs and provides recommendations to implement the requirements. The article includes portions of QSIT that utilize essential design outputs, provides a method to determine them, and explains an approach for internal audits to verify them.

Warning Letter on Monitoring Validated Processes Added

The Ombu Library, in the Warning Letter aisle, has analysis and recommendations of a Warning Letter involving monitoring validated processes as required by §820.75(b). In this Warning Letter, a company established process input parameters, but didn’t monitor them. This raises the question of producing and shipping nonconforming product.

Article on Transition to ISO 13485 added to the Ombu Library

There is a new article in the Ombu Library on transition to ISO 13485:2016. It covers expiration of certificates to the international standards, MDSAP, Health Canada, and expiration of certificates in the EU.

 

Look for the article, Transition to ISO 13485, in the ISO 13485:2016 aisle.

FDA Updated Training Module on Early Feasibility Studies

FDA has updated the CDRH Learn Module on Early Feasibility Studies for Medical Devices to include a new section on the Device Evaluation Strategy. The updated section of the module provides information on developing a Device Evaluation Strategy.

 

The updated module is available through CDRH Learn at http://www.fda.gov/Training/CDRHLearn/default.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

 

Open the dropdown �How to Study and Market Your Device� and look for �Clinical Studies/Investigational Device Exemption (IDE)�

FDA Training Modules on MDSAP

FDA has prepared 10 training modules on the Medical Device Single Audit Program (MDSAP). The modules are available through CDRH Learn at http://www.fda.gov/Training/CDRHLearn/default.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Open the dropdown for Postmarket Activities and look for Inspections - Global Harmonization.

In addition to a Primer by Kim Trautman, the 10 modules are:

1. Introduction to MDSAP

2. MDSAP Management

3. MDSAP Device Marketing Authorization and Facility Registration

4. MDSAP Measurement, Analysis, and Improvement

5. MDSAP Medical Device Adverse Events and Advisory Notices Reporting

6. MDSAP Design and Development

7. MDSAP Production and Service Controls, part 1

8. MDSAP Production and Service Controls, part 2

9. MDSAP Production and Service Controls, part 3

10. MDSAP Purchasing

UDI Extension Letter

On September 6, 2016, FDA-CDRH issued a letter to device labelers extending the compliance date for UDI label and GUDID submission requirements, in some specific cases, to September 24, 2018. The letter is available at http://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM519346.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

There are three cases covered by the letter.

For two or more different devices packaged together, 801.30(a)(11) allows an exemption to including a UDI on the devices inside as long as the label carries a UDI for the package. FDA issued draft guidance document explaining when this exemptions applies and when it does not. The extension allows FDA to time to issue the final guidance.

For two or more of the same single use devices packaged together, 801.30(a)(3) allows an exemption to including the a UDI on the devices inside as long as the label carries a UDI for the package. The extension applies to repackagers, i.e., a firm that packages finished devices from bulk or repackages devices made by a manufacturer into different containers (excluding shipping containers).

For co-packaged or cross-labeled combination products, 801.30(a)(11) allows an exemption to including a UDI on the device constituent as long as the package label carries a UDI. The extension applies to combination products assigned to Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) for premarket review and regulation.

For specific details in all three cases, refer to the letter.

Draft Guidance on Additive Manufacturing

On May 10, 2016, FDA-CDRH issued a draft guidance on additive manufacturing, Technical Considerations for Additive Manufactured Devices (UCM499809). This is a leap-frog guidance, intended to share initial thoughts regarding emerging technologies likely to be of public health importance.

The draft guidance includes two topic areas: Design and Manufacturing Considerations and Device Testing Considerations. The Design and Manufacturing Considerations section provides technical considerations in fulfilling Quality System (QS) requirements for the device. The Device Testing Considerations section describes the information to provide for premarket notification submissions [510(k)], premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, de novo requests, and investigational device exemption (IDE) applications.

Article on MDR Exceptions and Variances added to the Ombu Library
(New) Article on Determining Requirements Related To Products Added to the Ombu Library

The medical device reporting regulation, Part 803, has provisions to grant exceptions and variances for specific types of reporting. This article describes four situations. The article is in the Medical Device Regulations aisle of the Ombu Library.

UPC Allowed for Some Devices

FDA-CDRH has recognized that retail establishments are better prepared to identify a device through a UPC than a UDI, because the technology is not prepared to read a UDI in AIDC form. As a result, there is an alternate for some devices until September 24, 2021; FDA anticipates that by that date, retail establishments will have UDI-compatible technology in place.

The alternative has the following conditions:

�������� A specified list of product codes

�������� Not intended to be sold exclusively by prescription

�������� Not sold to, distributed to, or used in health care settings

�������� The UPC is the primary device identifier (DI) in GUDID

�������� The alternative is documented in the DMR, �820.181(d), and copy of the alternative is also in the DMR

The alternate is available on the FDA website at UCM517297, which links to the list of product codes.

Article on Record Retention Added

The Ombu Library has a new article on record retention for device manufacturers. This article identifies parts of the FDA regulations for device manufacturers that include record and record retention requirements. The article provides a framework to help understand record retention requirements. The article is in the medical device regulations aisle.

Article on Kits, Packaging Configurations, and Unit-of-Use Added

The Ombu Library has a new article on UDI related to kits, packaging configurations, and Unit-of-Use in the UDI aisle. This article explains these concepts using simple examples without the often confusing technical definitions. The article provides an understanding of the concepts, illustrates how the device identifiers are related, and show the relevant portion of GUDID entries.

510(k) Change Draft Guidance Document

After much controversy and a long wait, FDA-CDRH recently released two draft guidance documents related to making changes in 510(k) cleared devices. FDA had previously released a controversial draft, but Congress passed a law, FDASIA, instructing FDA to withdraw the guidance and meet other conditions.

The draft guidance documents are the result of a public meeting and comments to docket.

Deciding When to Submit a 510(k) for a Change to an Existing Device, is the more broad draft guidance, while Deciding When to Submit a 510(k) for a Software Change to an Existing Device, covers the more specific software changes.

FY17 Medical Device Fees

FDA set the medical device fee structure for FY17 (Oct. 1, 2016 to Sep. 30, 2016)

Activity

Standard Fee

Small Business Fee

Establishment Registration

$3,382

$3,382

510(k)

$4,690

$2,345

513(g)

$3,166

$1,583

PMA, PDP, PMR, BLA

$234,495

$58,624

panel-track supplement

$175,871

$43,968

180-day supplement

$35,174

$8,794

real-time supplement

$16,415

$4,104

BLA efficacy supplement

$234,240

$58,560

annual report

$8,207

$2,052

30-day notice

$3,752

$1,876

Draft Guidance on UDI Form and Content

On July 26, 2016, FDA-CDRH released a draft guidance Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI).

The guidance includes some definitions that are important, but not included in the UDI rule. These include Data Delimiter, Easily Readable Plain-Text, and UDI Carrier. It also reiterates the definition of Automatic Identification and Data Capture (AIDC) from the rule.

The manufacturer presents the UDI on the device label two forms, the AIDC and the Easily Readable Plain-Text. The draft guidance clarifies that the AIDC allows data entry into an electronic health record. The Easily Readable Plain-Text is a legible interpretation of the characters in the AIDC including the data delimiters.

Revised MedDev on Standalone Software

In July 2016, the EU issued a revised guidance document on standalone software. The document is MedDev 2.1/6 Guidelines On The Qualification And Classification Of Stand Alone Software Used In Healthcare Within The Regulatory Framework Of Medical Devices.

The revision defines the term software as a set of instructions that processes input data and creates output data. It also has definitions for input data and output data.

Obtain a copy from https://ec.europa.eu/growth/sectors/medical-devices/guidance_en

Usability Guidance Document Referenced

In an update to the list of recognized standards (Recognition List #43) FDA-CDRH included references to the recent Guidance Document on human factors and usability engineering. The guidance, issued on February 3, 2016, is Applying Human Factors and Usability Engineering to Medical Devices - Guidance for Industry and Food and Drug Administration Staff.

The guidance is listed for ISO 14971:2007, IEC 60601-1-6:2013, IEC 60601-1-8:2006, IEC 62366:2014, IEC 62366-1:2015, and AAMI/ANSI HE75:2009/(R)2013. It also includes any corresponding US versions of international standards.

The list is in the OMBU Library in the Usability Engineering aisle.

Warning Letter on MDRs Added

The Ombu Library has analysis and recommendations of a Warning Letter involving failure to submit a Medical Device Report for a malfunction as required by Part 803. In this Warning Letter, a firm initiated complaints, but failed to recognize that they must also report them as MDRs.

Revised EU Guidance on Clinical Evaluation

In June 2016, the EU published a revised version of the guidance document on Clinical Evaluation. This version, MedDev 2.7/1 Rev. 4, published in June 2016, includes significant changes from the previous version.

The new version is effective immediately, but it not clear how it would affect existing Clinical Evaluation reports.

However, section 6.2.3.a provides information on the frequency of clinical evaluation updates.

The clinical evaluation is actively updated:

when the manufacturer receives new information from [post market surveillance] that has the potential to change the current evaluation;

if no such information is received, then

o at least annually if the device carries significant risks or is not yet well established; or

o every 2 to 5 years if the device is not expected to carry significant risks and is well established, a justification should be provided.

When involvement of notified bodies is required, updates are usually coordinated with the notified body. Typically, they are aligned with the timetable for surveillance audits and the renewal of the certificates.

Final Rule on Use of Symbols

Under a final rule, device labels marketed in the US may use a symbol without adjacent explanatory text. This new rule, which goes into effect on September 13, 2016 Revises Part 660 Additional Standards For Diagnostic Substances For Laboratory Tests, Part 801 Labeling, and Part 809 In Vitro Diagnostic Products For Human Use.

https://www.gpo.gov/fdsys/pkg/FR-2016-06-15/html/2016-13989.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

The new rule does not require a label but allows an option. Some conditions apply to exercise the option.

1) The symbol comes from a recognized standard and the use conforms to the standard.

2) The symbol comes from an unrecognized standard, the use conforms to the standard, and the manufacturer determines the symbol is likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

3) The symbol comes from a recognized standard, the use is NOT in conformity with the standard, and the manufacturer determines the symbol is likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

In all these cases, the manufacturer prepares a glossary of the symbols and meanings and makes it available as part of the device labeling.

In conjunction, Recognition List No. 42 modified the recognition of five standards and added three standards.

https://www.gpo.gov/fdsys/pkg/FR-2016-06-15/pdf/2016-13990.pdf

FDA-CDRH Webinar on Biocompatability

On July 21, 2016, the FDA will hold a webinar for industry to review the Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" final guidance document. The recommendations in this final guidance clarify and update how medical device developers may use ISO 10993-1 standard in their premarket submission to determine the potential for an unacceptable adverse biological response resulting from contact of a medical device with the body.

Webinar Details: Registration is not necessary

Date: July 21, 2016

Time: 1:00 -2:30 PM, Eastern Time.

To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar.

NOTE: You must dial-in to hear the presentation and ask questions:

Dial: 888-664-9861, passcode: 8730789

International Callers Dial: 1-630-395-0354

To view the slide presentation during the webinar:

https://www.mymeetings.com/nc/join.php?i=PW8727057&p=8730789&t=c

Conference Number: PW8727057

FDA-CDRH Guidance on Biocompatability

FDA issued the final guidance on biocompatibility, UCM348890. Entitled Use Of International Standard ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process, it replaces Blue Book Memorandum #G95-1 (1995), Use Of International Standard ISO 10993, Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing.

The guidance assists industry in PMAs, HDEs, IDEs, 510(k)s, and de novo submissions for medical devices that come into direct or indirect contact with the human body to determine the potential for an unacceptable adverse biological response.

The guidance is limited to the biological evaluation of sterile and non-sterile medical devices that come into direct or indirect contact with the human body and covers the following topics:

Use of risk assessments for biocompatibility evaluations for a proposed medical device

Use of ISO 10993-1:2009 and the FDA-modified matrix to determine the relevant biocompatibility endpoints for an evaluation

General biocompatibility testing considerations, including test article preparation

Specific considerations for cytotoxicity, sensitization, hemocompatibility, pyrogenicity, implantation, genotoxicity, carcinogenicity, reproductive and developmental toxicity, and degradation assessments

Chemical assessment recommendations; and considerations for labeling devices as -free

Draft EU MDR & IVDR Available

A draft of the EUs Medical Device Regulation is available at item #13.

A draft of the EUs In vitro Diagnostic Regulation is available at item #14.

http://www.emeeting.europarl.europa.eu/committees/agenda/201606/ENVI/ENVI%282016%290615_1/sitt-2571599

The EU must write them in the final form and translate them into the official languages before they can issue the regulations officially. That starts the transition period to bring the regulations into force.

Warning Letter on Quality Audits Added

The Ombu Library has analysis and recommendations of a Warning Letter involving failure to properly assign an auditor as required by 820.22. In this Warning Letter, a firm didnt follow its own procedure and assigned an auditor to an area for which the auditor had direct responsibility. The firm responded, but the FDA concluded that the response was not adequate.

FDA-CDRH Draft Guidance on Accesories

On January 20, 2015, FDA-CDRH published a draft guidance document, UCM429672, Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types. The intent is define when an article is an accessory and for accessories determine the risk and control levels.

The draft guidance offers some definitions.

Accessory: A device that is intended to support, supplement, and/or augment the performance of one or more parent devices.

Parent Device: A finished device whose performance is supported, supplemented, and/or augmented by one or more accessories.

It also includes addition information on use with a parent device, as well as a discussion of the terms support, supplement, and augment.

The docket number at www.regulations.gov is FDA-2015-D-0025. At the docket, you may read the comments posted.

FDA-CDRH Guidance on Human Factors

On February 3, 2016, FDA-CDRH issued a final guidance document entitled Applying Human Factors and Usability Engineering to Medical Devices. The guidance document recommends applying human factors in a risk management setting as a particular instance of ISO 14971:2007. In particular, the guidance discusses use-related hazards as a particular type of hazard. Use-related hazards might result from aspects of the user interface design that cause the user to fail to adequately or correctly perceive, read, interpret, understand or act on information from the device.

The guidance advises that because probability is very difficult to help determine the risk of use errors, the severity of the harm is more meaningful for estimating risk and evaluating the need for risk control.

In addition, a draft guidance, List of Highest Priority Devices for Human Factors Review, dated February 3, 2016, lists sixteen device types, some with multiple product codes, for which a premarket submission should include human factors data.

Agreement Reached on EU Medical Device Regulation

The parties involved in negotiating the new Medical Device Regulation have reached agreement on the issues. The EU published a press release in May 25, 2016 announcing the result. The agreement includes the regulation for in vitro diagnostic devices.

The next steps include formal adoption by European Council and the Parliament. The Medical Device Regulation goes into three years after publication and the In Vitro Diagnostic Device Regulation goes into effect five years after publication. The text of the agreed regulation is not yet available. The press release discusses some of the extensive changes.

http://www.consilium.europa.eu/en/press/press-releases/2016/05/25-medical-devices/?utm_source=dsms-auto

MDD Harmonized Standards Updated

The European Commission updated the list of standards harmonized to the Medical Device Directive (MDD) on May 13, 2016. The list is available at http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices/index_en.htm

The new list does not include the EU versions of ISO 13485:2016, IEC 62366-1:2015, or Amendment 1 to IEC 62304:2006.

The new standards are: EN 556-2:2015, EN 1865-1:2010+A1:2015, EN 1865-2:2010+A1:2015,

EN ISO 3826-4:2015, EN ISO 11137-1:2015, EN ISO 11137-2:2015, EN ISO 13408-1:2015, EN ISO 13408-7:2015, and EN 60601-1-2:2015.

IEC/TR 62366-2:2016 Published

In April 2016, the International Electrotechnical Commission (IEC) published IEC/TR 62366-2:2016 Medical Devices Part 2: Guidance on the Application of Usability Engineering to Medical Devices

As stated in the introduction, This technical report provides medical device manufacturers with guidance on how to integrate usability engineering (also called human factors engineering) principles and user interface design practices into their overall medical device development processes. The technical report recognizes that all medical devices involving human interaction present opportunities for optimization through the application of usability engineering and seeks to guide the medical device manufacturers efforts.

The technical report includes two normative references.

IEC 62366-1:2015 Medical Devices Part 1: Application of Usability Engineering to Medical Devices

ISO 14971:2007 Medical Devices Application of Risk Management to Medical Devices

Draft Cybersecurity Post-Market Guidance Document

FDA-CDRH published a draft guidance document on post-market cyber security. The draft guidance, issued on January 22, 2016, is entitled Postmarket Management of Cybersecurity in Medical Devices.

The guidance document is extensive and covers many areas of cybersecurity. The concept includes a relationship to ISO 14971:2007 as a method to collect and analyze the information and update the risk management files.

It also offers guidance on software updates and when they are reportable as a correction or removal under Part 806.

One may submit comments at www.regulations.gov to Docket number FDA-2015-D-5105.

Warning Letter on Complaints and Warranty Added

The Ombu Library has analysis and recommendations of a Warning Letter involving recognizing warranty claims as complaints under 820.198. In this Warning Letter, a company had processed warranty claims, but had not considered them for inclusion as a complaint or required investigation.

IEC 61882:2016 Published

On March 3, 2016, a new edition became available. IEC 61882:2016 Hazard and Operability Studies (HAZOP Studies) - Application Guide provides information on HAZOP studies using guide words. The new version includes definitions, preparation, examination sessions, documentation and follow-up. According to the IEC website the new edition includes significant technical changes including:

Clarification of terminology

Alignment with terms and definitions within ISO 31000:2009 and ISO Guide 73:2009

An improved case study of a procedural HAZOP

HAZOP is one of the supporting tools cited in Annex G of ISO 14971:2007 Medical Devices Application of Risk Management to Medical Devices

CDRH Learn Modules Added

FDA-CDRH recently announced the addition of five new modules to the CDRH Learn Program website. CDRH Learn is a set of online education modules designed to provide information on medical device laws, regulation, and policies. The main page, which provides access to the modules, is http://www.fda.gov/training/cdrhlearn/default.htm

The newly added modules are:

Unique Device Identification (UDI) System Regulatory Overview

Global Unique Device Identification Database (GUDID) Account Request: Preparation and Process

The GUDID Device Identifier (DI) Record

HL7 SPL Submission Option

Unique Device Identification (UDI) Part II, Submitting Information to GUDID

Warning Letter on Quality System Record Added

The Ombu Library has analysis and recommendations of a Warning Letter involving failure to establish a quality system record as required by 820.90. In this Warning Letter, a firm didnt create the required record. When the Investigator asked for it, the Owner said the information is in his head.

FDA-CDRH Library of Quality Practices

FDA-CDRH announced, as part of the Case for Quality initiative, a Library of Quality Practices. The resource helps medical device firms identify tools for quality in design and in manufacture. The library has three contributing organizations: the American Society for Quality (ASQ), AdvaMed, and the Medical Device Innovation Consortium (MDIC).

The links are:

FDA: http://www.fda.gov/medicaldevices/deviceregulationandguidance/medicaldevicequalityandcompliance/ucm378185.htm

ASQ: http://asq.org/fda-case-for-quality

AdvaMed: http://advamed.org/issues/35/case-for-quality

MDIC: http://mdic.org/cfq/maturity-model-report

Update to the List of Recognized Standards

FDA-CDRH announced an update to the List of Recognized Standards. The modification is Recognition List Number 41. The notice is the Federal Register is https://www.gpo.gov/fdsys/pkg/FR-2016-04-04/pdf/2016-07467.pdf

The list helps device manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. The guidance on the recognition and use of consensus standards is http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077295.pdf

FDA-CDRH maintains a searchable database of recognized consensus standards at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm

Supplier Management Comparative Analysis
The ISO 13485:2016 aisle in the Library contains a comparative analysis of supplier management processes and activities for QSR, ISO 13485:2003, and ISO 13485:2016
MDSAP to Replace CMDCAS

The Medical Device Single Audit Program (MDSAP) is a program initiated by the International Medical Device Regulators Forum (IMDRF). Under this program a single audit, performed by an authorized Auditing Organization (AO) would meet the QMS surveillance requirements of multiple regulatory authorities. Participating countries are Brazil, Canada, Japan, and the United States.

From January 1, 2017 to December 31, 2018, Health Canada will accept both MDSAP and CMDCAS (Canadian Medical Device Conformity Assessment System) certificates. From January 1, 2019, onwards Health Canada will accept only MDSAP certificates.

The transition to MDSAP aligns with the transition plan for QMS certificates from ISO 13485:2003 to ISO 13485:2016.

Information for Safety in Risk Management

One common problem encountered by device manufacturers is an assertion that the content deviations in EN ISO 14971:2012 says that Information for Safety does not reduce risk.

There are two simple refutations of this misunderstanding. A content deviation requires the cumulative application of all risk reduction measures including information for safety.

The content deviation usually cited deals with disclosure of residual risk and does not make any statement about information.

There is a new paper in the Risk Management for Medical Devices aisle that explains why the common assertion is not valid.

ISO 13485:2016 Transition

There are at least two transition issues related to the publication of ISO 13485:2016, certificates and status as an EU Harmonized Standard.

ISO 13485:2016 has a publication date of March 1, 2016. ISO/TC 210/WG1 recommends a transition scheme for certificates. Two years after publication (March 1, 2018), all new or recerifications should be to ISO 13485:2016. Three years after publication (March 1, 2019), ISO 13485:2016 certificates will not be valid. The accreditation bodies must act on this recommendation.

The second is the recognition of EN ISO 13485:2016 as a harmonized standard to the European directives. It is not yet a harmonized standard, but should be harmonized before June 30, 2016. Another issue is the date of cession of presumption of conformity for EN ISO 13485:2012. Technically, we dont know this, since it has not yet been harmonized. However, it is usually the date of withdrawal, DOW, set by the European standardization organization. In this case, CEN has set the DOW as March 31, 2019.

EN ISO 13485 2016 Published

EN ISO 13485:2016 is now available. Similar to EN ISO 13485:2012 it includes tables that shows the relationship between the conformity assessment paths in the MDD, AIMD, and the IVDD. For example, MDD Annex II Section 3.2.c, 9th indent requires a description of the clinical evaluation referred to in Annex X. However, the new QMS standard doesnt cover this requirement. Table ZB.1 says that 7.3.7, Design and development validation, does not include the details of Annex X.

ISO 13485:2016 Published

The third edition of this standard for a medical device Quality Management System (QMS) is published with a date of March 1, 2016. It has eight major clauses, similar to ISO 13485:2003.

Scope

Normative References

Terms and Definitions

Quality Management System

Management Responsibility

Resource Management

Product Realization

Measurement, Analysis, and Improvement

The third edition cancels and replaces the second edition (ISO 13485:2003) as well as ISO/TR 14969:2004.

This new edition is a stand-alone standard based on ISO 9001:2008, not the current version ISO 9001:2015.

Docket on Refurbishing, Rebuilding, Remarketing, Remanufacturer, and Servicing

FDA has requested comments on the regulation of companies that refurbish, recondition, rebuild, remanufacture, or service medical devices. This includes both third parties and the original device manufacturer.

The notice says that FDA would like to clarify these regulations. In particular, it notes that QSR in 21 CFR Part 820 does not cover refurbishers and servicers. However, QSR does include requirements for installation and servicing by the manufacturer.

The request offers definitions for the terms recondition, service, repair, refurbish, remanufacture, and remanufacture. It asks for comments and clarification of the proposed definitions.

The notice also invites comments on a set of questions.

FDA intends to hold a public meeting in 2016 informed by the comments submitted to the docket.

One may submit comments at www.regulations.gov to Docket number FDA-2016-N-0436.

Warning Letter on Environmental Conditions Added

The Ombu Library has analysis and recommendations of a Warning Letter involving environmental controls required by 820.70(c). In this Warning Letter, a company developed procedures for electrostatic discharge (ESD), but the FDA Investigator observed they were not followed.

Warning Letter on Nonconforming Product Added

The Ombu Library has analysis and recommendations of a Warning Letter involving control and disposition of nonconforming product required by 820.90. In this Warning Letter, a didnt establish requirements for documenting the review and disposition of nonconforming product or require documented justification and approval for use of nonconforming product.

Warning Letters Added

The Ombu Library has a new aisle. From time to time, the library will contain excerpts from FDA Warning Letters. These excerpts include the background of the requirement, the problem cited by FDA, and recommendations to avoid a similar problem.

Medical Device Excise Tax Suspended

Medical Device Excise Tax Suspended

The President signed the Consolidated Appropriations Act, 2016 into law on December 18, 2015. 29 CFR 4191 implements the medical device excise tax. The law adds a new subsection (c) Moratorium The tax imposed under subsection (a) shall not apply to sales during the period beginning on January 1, 2016, and ending on December 31, 2017. As a result, the medical device excise tax does not apply to the sale of a taxable medical device by the manufacturer, producer, or importer of the device from Jan. 1, 2016 to Dec. 31, 2017.

LDT Guidance Due in 2016

FDA has asserted it authority to regulate Laboratory Developed Tests, LDTs, as medical devices. In 2016, FDA plans to publish guidance documents explaining the process for bringing devices into the regulatory structure. This will end FDAs policy of enforcement discretion in which it didnt, for historical reasons, enforce the device regulations.

Currently, there are draft guidance documents that describe the approach FDA intends to take. However, there was a public meeting on this issue as well as a comment period. These could have significant influence on FDAs enforcement plan.

GUDID Availability for Class 2 Labelers

GUDID Availability for Class 2 Labelers

Beginning February 1, 2016, FDA will accept GUDID account requests from labelers of Class 2 devices. These labelers should set up a GUDID account as soon as possible to allow adequate time for system compatibility testing and data submission. FDA expects a large submission volume in 2016 because of the number of Class 2 devices. The compliance date for Class 2 labels, packages, date format, and GUDID submissions is September 24, 2016.

Usability Engineering Article Added to the Library
The Medical Device Regulations aisle in the Ombu Library has a new entry on setting Quality Objectives

The Usability Engineering aisle in the Ombu Library has a new entry on the recently published standard. The article describes the the new process in IEC 62366-1:2015. The article includes a number of diagrams.

Setting Quality Objectives
The Medical Device Regulations aisle in the Ombu Library has a new entry on setting Quality Objectives

The Medical Device Regulations aisle in the Ombu Library has a new entry on setting Quality Objectives. The article describes the relationship between the Quality Policy and the Quality Objectives. It illustrates some simple Quality Policies and then develops some representative Quality Objectives. They should be measurable, so the article discusses the metric classification system of efficiency, effectiveness, and cycle-time. The representative Quality Objectives are classified using this framework. In addition, the metrics should have operational definitions as well as graphical representations. The article provides definitions and recommends graphical methods for each kind of metric type.

Preparing for eMDR
On August 14, 2015 the eMDR rule becomes effective. This article, in the Medical Device Reports section of the Library, provides an overview of the implementation.
UDI Implementation Seminars in Springfield, MA and Albany, NY
Implementing UDI will have many challenges, especially for the small manufacturer

Implementing UDI will have many challenges, especially for the small manufacturer. Now is the time to start planning your approach and identify the resources you need. You can avoid the last minute scramble.

Implementing UDI: Meeting the Challenges

An Ombu Enterprises Seminar

Ombu is offering two local seminars to help you prepare.

Springfield, MA April 18, 2014

Albany, NY May 2, 2014

Implementing UDI Meeting the Challenges is a seminar you cannot afford to miss because it addresses all aspects of the UDI rule. You will receive tools to help you understand the regulations, update your procedures, and make the critical decision you need for implementation.

Many of the challenges come from the complexity of the regulation, the many decisions you must make, and the resources you must provide.

Do you know the compliance date for your device? The device class is one factor, but other factors enter as well. You must have everything in place by your compliance date.

The rule will change the label on your device and your packages to include the UDI = DI + PI and a new date format. The DI (Device Identifier) is mandatory, but the PI (Production Identifiers) are optional. How will you decide which ones to use?

Have you established the packaging hierarchy for your devices so you can put the correct UDI on each packaging level?

On the compliance date, your labels and packages need the new date format with year, month, and day. If you have only used month and year, how will decide what day is appropriate?

You must contract with an FDA-CDRH accredited agency to obtain the UDI information. To date, there are only three choices. Do you have criteria in place to help you make this supplier selection and document it under 820.50?

You will need at least two other suppliers, one to issue a DUNS number for your company and one to issue GMDN codes for your devices. Are you prepared to select these new suppliers and pay the fees?

For every device you sell, you must identify the data to populate the new database called GUDID. You will have to make decisions for about 50 data fields for every device! Do you know the extent of the data and have the resources in place?

You must load the data for all of your devices using either the FDA-CDRH web interface or HL7 information. Do you know the pros and cons of each method?

The cost for each session is only $425.00 per person. For two or more people from the same company in the same session, the cost per person goes down to $380.00. This affordable price allows you to bring team members. Each session runs from 9 a.m. to 4 p.m. and includes lunch and light refreshments during breaks.

For more information and registration, please contact Seminars@OmbuEnterprises.com.

UDI Implementation Seminars
Ombu Enterprises, LLC is offering a series of UDI implementation seminars

Ombu Enterprises, LLC is offering a series of UDI implementation seminars.

Unique Device Identification (UDI) implementation is more than just changing the label on your device! You need to prepare for UDI since it affects every part of your medical device quality management system. This hands-on seminar can help you get ready.

The new regulation requires that you add the UDI information and change the date format on your labels. You need to implement UDI label changes for all of your standard packaging configurations. For example, if you ship five devices in a carton, you need a UDI label for each device and a separate UDI label on the carton.

The preliminary seminar schedule is listed below. Because the schedule can change, please contact us for additional information.

The cost is $425 per person with a discount for multiple people from the same company.

The seminars are also listed on the Seminar page.

Nashua, NH March 14, 2014

Needham, MA March 28, 2014

Providence, RI April 4, 2014

Springfield, MA April 18, 2014

Albany, NY May 2, 2014

New Haven, CT May 30, 2014

Newark, NJ June 13, 2014

GMDN Codes and GUDID
(New) GMDN Codes and GUDID

(New) GMDN Codes and GUDID

The Global Unique Device Identification Database (GUDID) requires the Global Medical Device Nomenclature (GMDN) PT Code. The final rule for Unique Device Identification (UDI) said that FDA-CDRH would allow a [user] who reports data to the GUDID to enter a GMDN code if the [user] knows it, or may use a module integrated in the GUDID reporting system to search for and select an appropriate GMDN term.

FDA-CDRH has developed a new GUDID module, Find FDA PT Codes, to enable users to select a FDA PT Code for GUDID submissions until a GMDN PT code can be obtained from the GMDN Agency. FDA PT Codes are a unique 4-letter code assigned to each GMDN PT Name, in place of the GMDN PT Code. The Find FDA PT Code module is enabled in GUDID Release 1.1 and can be accessed via the GUDID Web Interface by Coordinator and Labeler Data Entry (LDE) Users of GUDID. These FDA PT codes can also be submitted in HL7 SPL xml submissions.

UDI Accredited Agencies
(New) UDI Accredited Agencies

FDA-CDRH recently increased the list of accredited agencies for UDI. There are 3 accredited agencies: GS1, Health Industry Business Communications Council (HIBCC), and ICCBBA.

Medical device manufacturers must use an accredited agency to issue a UDI and populate the GUDID. To learn the details of these accredited organizations, go to the FDA-CDRH website at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm

Ombu Comments of Risk Management in Cybersecurity Draft Guidance
In June 2013, CDRH and CBER published a draft guidance on cybersecurity and pre-market submissions. The draft guidance uses risk analysis in 820.30 to evaluate cybersecurity. The comments, in the Ombu Librarys Risk Management for Medical Devices section, suggests a more explicit use of ISO 14971:2007.
Recording Acceptance Sampling Results
An article in the Acceptance Sampling aisle discusses an issue with recording the results of acceptance activities. The Baltimore District Office cited a company for recording x for a sampled unit out of specification instead the actual value. The article discusses regulatory requirement and explains why the Warning Letter is incorrect. It also explains the best practice, Z1.9, for sampling when you measure the actual value. Dont convert to an attribute and use Z1.4.
Setting the Medical Device Lifetime
The Ombu Library has an article on setting the lifetime of a medical device. This includes issues related to record retention and to risk management. Look in the Medical Device Regulations section.
IMDRF Open Consultations
(New) IMDRF Open Consultations

(New) IMDRF Open Consultations

The International Medical Device Regulators Forum (IMDRF) currently has four open consultations. These are opportunities for people to comment on work underway. The consultations are available at http://www.imdrf.org/consultations/consultations.asp

Each consultation includes documents, a comment sheet, and an e-mail address to send the comments.

The consultations are, with their closing dates:

Regulated product submission (RPS) Table of contents June 21, 2013

Auditor competency and training requirements for organizations undertaking audits of medical device manufacturers June 14, 2013

Recognition and monitoring of organizations undertaking audits of medical device manufacturers June 14, 2013

UDI System for Medical Devices July 31, 2013

Dan OLeary to Join a Panel Discussion on UDI
On June 4, 2013, Dan OLeary will join a panel of other experts to discuss the UDI Rule and what it means to device manufacturers. The panel discussion is part of the Tenth Annual Medical Device Quality Congress sponsored by FDA News. http://www.fdanews.com/conference/detail?eventId=3232
UDI Final Rule Timing
There is a new article in the Ombu Library, in the Medical Device Regulations Section, on the timing of the UDI final rule. FDA plans to issue it by June 30, 2013, but some members of Congress believe the law requires a publication date before May 7, 2013.
Updated List of MDD Harmonized Standards
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EU Publishes New List of Standards Harmonized to the MDD

On August 30, 2012, the European Union published an updated list of standards harmonized to the Medical Device Directive (MDD).

Health Canada Updates Recognized Standards

(New) Health Canada Updates Recognized Standards

On July 27, 2012 Health Canada issued a new list of recognized standards. The issuing notice says the changes consist of:

a. 16 new editions of currently recognized standards were added to replace previous editions;

b. 13 superseded standards were removed.

These changes are required in order to harmonize the list with the previously published guidance on the transition between second and third edition versions of the IEC 60601 family of standards which took effect June 1, 2012.

The recognition document is available as a PDF at http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/md-im/standards-normes/md_rec_stand_im_norm_lst-eng.pdf

CDRH Learn Course Updates
FDAs Center for Devices and Radiological Health (CDRH) offers online courses to help medical device manufacturers. The list below includes the complete list of courses in English, including some recently updated. The URL for the courses is http://www.fda.gov/Training/CDRHLearn/ucm162015.htm

Course List
  • Overview of Regulatory Requirements: Medical Devices [Updated 11/29/2011]
  • Guidance Documents and Standard Operating Procedures (SOPs) [Updated 04/10/2012]
  • Premarket Notification Process - 510(k)
  • Investigational Device Exemption Process - IDE [Updated 2/23/2012]
  • Bioresearch Monitoring (BIMO) [Updated 2/23/2012]
  • Device Establishment Registration and Listing
  • CDRH Regulated Software: An Introduction
  • Quality System Regulation 21 CFR Part 820
  • Medical Device Recalls [Updated 2/23/2012]
  • Medical Device Reporting (MDR)
  • Export Certificates for Medical Devices
  • Regulation of Radiation-Emitting Products
  • Global Initiatives [Updated 03/23/2012]
  • Medical Devices in the Home
GHTF Adds Draft Guidance Document on Clinical Performance Studies in IVDs
The Global Harmonization Task Force (GHTF) issues guidance documents to help achieve greater uniformity between national medical device regulatory systems. The GHTF structure includes both Study Groups (SG) and Ad Hoc Working Groups (AHWG) in specific areas:

SG1 - Premarket Evaluation
SG2 - Post-Market Surveillance/Vigilance
SG3 - Quality Systems
SG4 Auditing
SG5 - Clinical Safety/Performance
AHWG - Global Model
AHWG - Unique Device Identification
AHWG - Regulatory Change Management

In February 2012, GHTF issued a draft guidance document as listed below

SG5 - Clinical Safety/Performance
SG5(PD)/N8R3 Clinical Performance Studies for In Vitro Diagnostic Medical Devices
The comment period ends June 2, 2012

You can download these documents from www.ghtf.org at no charge. The proposed documents have a comment period and the GHTF solicits comments.

IMDRF Web Site Is Available
The International Medical Device Regulatory Forum (IMDRF) held its inaugural meeting from February 28 to March 1, 2012 in Singapore. Regulators from Australia, Brazil, Canada, Europe, Japan, and the US attended the meeting. It also included observers from China, the Russian Federation, and the World Health Organization (WHO).

The meeting took steps to transition several key items from the Global Harmonization Task Force (GHTF) by the end of 2012. In addition, they created a list of work items:
  • Review the NCAR Exchange Program
  • A roadmap for implementation of a UDI system
  • Developing a medical device single audit program
  • Create a list of international standards recognized by members
  • Develop a messaging standard for electronic transmission of regulatory submissions
The forums web site is www.imdrf.org

FDA Issues Guidance on ISO 13485 Voluntary Audit Program
On March 19, 2012 FDA issued a guidance document setting up the program for voluntary submission of ISO 13458 audit reports. See UCM212798. By submitting two years of acceptable ISO 13485 audit reports, FDA can remove the firm from the routine inspection work plan for one year. Current law requires an FDA inspection for Class II and Class III device manufacturers once in every two-year period.

A device manufacturer can participate under the following conditions
  • The firm submits the audit report within 90 days of the audit
  • The audit uses ISO 13485:2003
  • The auditor is under the regulatory system of Canada, the European Union, Australia, or Japan
The firm submits two years of documentation including the audit report, any related correspondence or communication, and a copy of the ISO 13485 certificate. The documentation must be PDF files submitted electronically through the FDA eSubmitter system.

Article on Selection of Sampling Distributions Added To the Ombu Library

One quandary a Quality Engineer faces is the selection of a sampling distribution to model a particular problem. Often, this depends on characteristics of the problem. The paper, Selecting Discrete Sampling Distributions explains how to select the right distribution. The paper uses a flow chart, with some question, to lead the user to the right distribution. The paper also contains a short explanation of each distribution and an example.

A subsequent paper examines the methods to describe discrete distributions such as the probability mass function, the mean, the variance, etc. In addition, other papers provide detailed explanations of each distribution.

Readers can find the articles in the Statistical Distributions section of the Ombu Library.

GHTF Issues UDI Guidance

With the increased interest in Unique Device Identification (UDI) the Global Harmonization Task force (GHTF) issued a guidance document on developing a UDI that will satisfy international concerns. When a regulatory authority (such as a region or a country) develops a UDI system it will, when implemented, achieve a globally harmonized approach by following the principles in the GHTF guidance.

The guidance defines a UDI compromised of a Device Identifier (DI) and a Production Identifier (PI). The DI is a unique code specific to a model or version of a device, while the PI includes serial number, lot or batch number, expiration date, etc.

Under the guidance, a UDI System has three parts: a UDI developed to a global standard, application of the UDI to the device, and information in an accessible UDI database.

While the GHTF organization is principally by Study Groups, it also has Ad Hoc Working Groups. One of these, UDI Ad Hoc Working Group, issued the guidance document GHTF/AHWG-UDI/N2R3:2011 entitled Unique Device Identification (UDI) System for Medical Devices and issued on September 16, 2011.

The US has a UDI program operating in FDA. The President signed the law requiring UDI on September 27, 2007. The FDA has not issued UDI regulations.

Article on Determining Requirements Related To Products Added to the Ombu Library

ISO 13485:2003 clause 7.2.1 has specific expectations of the organization to determine product requirements. This article explains the requirements and provides examples. It also states the linkage to design inputs.

GHTF to restructure as IMDRF

The GHTF issued the following statement (corrected for grammar and spelling).

On Oct 6-7, 2011, representatives from the medical device regulatory authorities of Australia, Brazil, Canada, China, European Union, Japan, and United States, as well as the World Health Organization (WHO), met in Ottawa to address the establishment and operation of a new organization, the International Medical Device Regulators Forum (IMDRF). This Forum will accelerate international medical device regulatory harmonization. The Forums Management Committee, composed of regulatory officials, will provide guidance on strategies, policies, directions, membership, and activities. Furthermore the Management Committee will oversee Ad Hoc Working Groups which may draw upon expertise from various stakeholder groups such as industry, academia, health care professionals, and consumer and patient groups. The IMDRF will meet bi-annually with the inaugural meeting taking place in Singapore from February 28th, to March 1st, 2012 under the leadership of Australia. As part of these bi-annual meetings stakeholders will have an opportunity to learn of the work of the Forum, provide input on emerging issues and suggest potential new work items.

GHTF Adds New Guidance Documents in October, 2011

The Global Harmonization Task Force (GHTF) issues guidance documents to help achieve greater uniformity between national medical device regulatory systems. The GHTF structure includes both Study Groups (SG) and Ad Hoc Working Groups (AHWG) in specific areas:

SG1 - Premarket Evaluation

SG2 - Post-Market Surveillance/Vigilance

SG3 - Quality Systems

SG4 Auditing

SG5 - Clinical Safety/Performance

AHWG - Global Model

AHWG - Unique Device Identification

AHWG - Regulatory Change Management

In October 2011 GHTF issued some documents of interest described below.

SG1 - Premarket Evaluation

SG1(PD)/N078R03 Principles of Conformity Assessment for Medical Devices (Draft)

This document, when approved, supersedes GHTF/SG1/N40:2006 which provided guidance on the same topic.

SG1(PD)/N077R04 Principles of Medical Devices Classification (Draft)

This document, when approved, supersedes GHTF/SG1/N15:2006 which provided guidance on the same topic. It has been modified to:

clarify the basis of allocating medical devices to one of four classes;

change the rule applying to sterilisation and disinfection devices;

remove the inconsistency with GHTF/SG1/N011 Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED);

add a Section on the reclassification of medical devices; and

incorporate changes resulting from the public scrutiny process.

You can download these documents from www.ghtf.org at no charge. The proposed documents have a comment period and the GHTF solicits comments.

Article on Vocabulary and Definitions Added To the Ombu Web Site

The article explains how to clarify definitions and terms. It starts with an understanding of the specific vocabulary in a standard such as ISO 13485:2003. This standard applies to medical devices and includes some specific terms from that file. In addition, it also incorporates, by reference, technical terms in ISO 9000:2005.

The article explains the role of ISO 9000:2005 and explains how it organizes terms and provides diagrams that help improve understanding.

In addition, the article explains the role of an ISO guidance document that provides definitions of common terms used in the family of standards.

The article uses an example, from the requirements for customer supplied property, that illustrates using the various terms to help satisfy the requirement in a QMS

CDRH List of Planned Guidance Documents

FDA’s Center for Devices and Radiological Health (CDRH) published a list of guidance documents it intendeds to develop in Fiscal Year 2012 (FY12). Each year CDRH publishes a list and invites comments including draft language on the proposed topics and/or suggestions for new or different guidance documents. Submit electronic comments to http://www.regulations.gov at docket FDA-2007-N-0270.

 

The list includes:

510(k) Issues

  • 510(k) Modifications
  • 510(k) Paradigm (510(k) Program Guidance)

 

Medical Device Classification

  • Medical Device Classification Product Codes

 

Medical Device Reporting

  • Distinguishing and Reporting Medical Device Recalls from Product Enhancements
  • Medical Device Reporting
  • Electronic Medical Device Reporting

 

Standards

  • Appropriate Use of Consensus Standards in Premarket Submissions
  • Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program

 

Laboratory Developed Tests

  • Framework for Regulatory Oversight of Laboratory Developed Tests
  • FDA Notification and Medical Device Reporting for Laboratory Developed Tests
  • Quality System Requirements Guide for Laboratory Developed Tests

 

The full list of proposed guidance documents is at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109196.htm

 

 

Article on Excel Validation in Multiple Version Companies Added to the Library

Medical device manufacturers validate Excel spreadsheets. However when the version changes, from Excel 2003 to Excel 2007, for example, companies face a new set of issues. This is particularly important if some employees are on Excel 2003 and other on Excel 2007.

 

The article illustrates the problem using a simple example that relies on Conditional formatting used to track calibration status. The article, Excel Spreadsheet Validation with Multiple Versions is in the Medical Device Regulations section of the library.

GHTF Adds New Guidance Documents in September

The Global Harmonization Task Force (GHTF) issues guidance documents to help achieve greater uniformity between national medical device regulatory systems. The GHTF structure includes both Study Groups (SG) and Ad Hoc Working Groups (AHWG) in specific areas:

SG1 - Premarket Evaluation

SG2 - Post-Market Surveillance/Vigilance

SG3 - Quality Systems

SG4 – Auditing

SG5 - Clinical Safety/Performance

AHWG - Global Model

AHWG - Unique Device Identification

AHWG - Regulatory Change Management

 

In September, 2011 GHTF issued some documents of interest described below.

 

SG1 - Premarket Evaluation

Label and Instructions for Use for Medical Devices (Final)

 

SG5 - Clinical Safety/Performance

Clinical Evidence for IVD Medical Devices – Key Definitions and Concepts (Proposed)

Clinical Evidence for IVD Medical Devices – Scientific Validity Determination and Performance Evaluation (Proposed)

 

AHWG - Unique Device Identification

Unique Device Identification (UDI) System for Medical Devices (Final)

 

You can download these documents from www.ghtf.org at no charge. The proposed documents have a comment period and the GHTF solicits comments.

 

 

Health Canada Guidance on Electronic Submissions, Class III & IV

Health Canada issued a new guidance document entitled Guidance for Industry: Preparation of a Premarket Review Document in Electronic Format for a Class III and Class IV Medical Device Licence Application

 

This guidance, effective November 1, 2011, covers medical device licence applications and medical device licence amendment applications for both Class III and Class IV in vitro diagnostic devices (IVDDs) and non-IVDDs (medical devices). Therefore, as of November 1, 2011, all premarket review documents for Class III and Class IV medical device licence applications and licence amendment applications will be expected to be submitted in both paper and electronic formats and be structured and prepared using the specifications outlined in this notice.

 

The new guidance document refers to Preparation of a Premarket Review Document for Class III and Class IV Device Licence Applications published October 23, 1998 (http://www.hc-sc.gc.ca/dhp-mps/mdim/ applic-demande/guide-ld/prmkt2_precomm2-eng.php). together, they form the basis for submissions, but Sections 1.0 to 4.0 of the electronic folder structure differ from the paper-based guidance due to reorganization, however, no new content or forms are required.

 

You can obtain a copy of the new guidance from http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/md-im/activit/announce-annonce/notice_e-form_class_iii_iv_avis-eng.pdf

 

 

Understanding Standards Harmonized to the MDD published in the Ombu Library

The Ombu Library contains a brief article on the role of harmonized standards in compliance to the Medical Device Directive (MDD). The article explains the use of harmonized standards to satisfy the Essential Requirements in Annex I.

Harmonized Standards to MDD Updated

The EU updated the list of MDD Harmonized Standards on August 19, 2011.

 

The two most commonly cited standards did not change.

 

EN ISO 13485:2003/AC:2009 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

 

EN ISO 14971:2009 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

 

Some of the items marked new include:

  • Parts of EN ISO 13408 Aseptic processing of health care products
  • Parts of EN 13976 Rescue systems - Transportation of incubators

 

You can read the full list of harmonized standards at http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/medical-devices/index_en.htm

 

Article on Preventive and Corrective Action Added to the Ombu Library

An article that helps clear up the confusion between corrective action and preventive action is in the Ombu Library. Many people fall into the “language trap” because they want to prevent a detected problem from happening again. Unfortunately, this does not agree with the definitions in ISO 9000 family of quality management standards. In that family there is a distinction between a detected nonconformity and a potential nonconformity which carries over into corrective action and preventive action. The article explains the difference between preventive action and corrective action and illustrates the difference with examples.

 

You can read the article in the CAPA Systems section of the library.

FDA Sets FY 2012 Medical Device Fees

 

In a Federal Register Notice published August 1, 2011 [Docket No. FDA-2011-N-0542], FDA set the rates for medical device user fees. The rates include a standard fee and a fee for small business. A company with no more than $100 million in sales in the most recent tax year may qualify for the reduced small business fee. A business with gross sales of no more than $30 million may also qualify for a waiver of the fee for the first premarket application (PMA, PDP, or BLA) or premarket report.

 

The table below shows the FY 2012 fee schedule.

 

Application fee type

Standard fee

Small business fee

Premarket application (a PMA submitted under section 515(c)(1) of the FD&C Act (21 U.S.C. 360e(c)(1)), a PDP submitted under section 515(f) of the FD&C Act, or a BLA submitted under section 351 of the Public Health Service (PHS) Act (42 U.S.C. 262)).

$220,050

$55,013

Premarket report (submitted under section 515(c)(2) of the FD&C Act).

$220,050

$55,013

Efficacy supplement (to an approved BLA under section 351 of the PHS Act).

$220,050

$55,013

Panel-track supplement

$165,038

$41,259

180-day supplement

$33,008

$8,252

Real-time supplement

$15,404

$3,851

510(k) premarket notification submission

$4,049

$2,024

30-day notice

$3,521

$1,760

513(g) (21 U.S.C. 360c(g)) request for classification information.

$2,971

$1,485

FDA Issues Draft Guidance on Changes to Products Covered By a 510(K)

On July 27, 2011 FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) issues a draft guidance document on when to submit a 510(k) for a change to an existing device.

 

This draft guidance is one of 25 specific actions that FDA intends to improve the premarket review programs. When issued, the guidance will replace the 1997 version, Deciding When to Submit a 510(K) for a Change to and Existing Device.

 

Among the drivers for change include the Quality System Regulation (QSR), issued after the 1997 guidance, software issues, and other rapidly changing technologies.

 

The 1997 version uses a decision process driven by a set of flowcharts. The draft guidance eliminates the flowcharts, but uses a large number of examples to illustrate the principles.

 

The guidance documents help manufacturers to implement 21 CFR §807.81(a)(3). That require a 510(k) submission when:

(3) The device is one that the person currently has in commercial distribution or is reintroducing into commercial distribution, but that is about to be significantly changed or modified in design, components, method of manufacture, or intended use. The following constitute significant changes or modifications that require a premarket notification:

(i) A change or modification in the device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process.

 

(ii) A major change or modification in the intended use of the device.

 

The draft guidance addresses the following areas:

·        Manufacturing Process Changes

·        Labeling Changes

·        Technology, Engineering, and Performance Changes

·        Materials Changes

·        Is Clinical Data Necessary to Determine Substantial Equivalence?

 

The draft guidance document stresses that the manufacturer should not evaluate each change alone, but in context with any earlier changes. The idea is to compare the device, after the proposed change, with the current cleared 510(k) for the device. This ensures that the proposed change includes the cumulative impact of all changes.

 

Each section, except the last, includes a series of questions, explanations, and example. For example, Technology, Engineering, and Performance Changes asks, “Is it a change in energy type?” the explanation includes, “Energy type refers to the type of power input to or output from the device.” The example tells us “A device that is changed from an external power source to battery power should result submission of a new 510(k).”

 

You may get a copy of the draft guidance using the search engine at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm.

 

You may comment on the draft through [FR Doc No: 2011-18923] at http://www.regulations.gov.

Article on Lot Acceptance Sampling in MIL-STD-1916 in the Ombu Library

MIL-STD-1916 contains the Department of Defense (DoD) preferred method for product acceptance. It seeks process control and statistical control methods, but does provide sampling inspection plans for lot acceptance by attributes. The article describes the plans. It explains the concept of AQLs and describes some of the reasoning why the standard uses verification levels instead. The article also provides some examples to determine the sampling plan.

 

You can read the article in the Acceptance Sampling section of the library.

GHTF Posts New Documents

The Global Harmonization Task Force (GHTF) recently posted two new documents.

 

The GHTF Steering Committee posted a final document entitled "Definition and Glossary of Terms Used in GHTF Documents". This document has a list of the definitions used in GHTF final documents. By consolidating the definitions into a single list, GHTF produced a useful Glossary of Terms.

 

GHTF Study Group 2 (Post-Market Surveillance/Vigilance) and Study Group 5 (Clinical Safety/Performance) published a proposed document for comment. The document is entitled “Reportable Events During Pre-Market Clinical Investigations” and is open for comment until December 10, 2011. The document is intended as a global model to provide guidance on the types of adverse events to report to National competent Authorities when conducting clinical investigations. The proposed document also utilizes ISO 14155:2011 Clinical Investigations of medical devices for human subjects – Good clinical practice.

 

Note that as of July 3, 2011

  • ISO 14155 is not an FDA recognized consensus standard.
  • ISO 14155:2011 is not harmonized to the MDD (but the earlier version is.)
Recast RoHS Directive Published

The recast Restriction on Hazardous Substances (RoHS) (Directive 2011/65/EU) appeared in July 1, 2011 edition of the Official Journal of the European Union. The recast directive now includes medical devices that are also electrical and electronic equipment.

 

The directive applies to medical devices placed on the market after July 22, 2014 and in vitro diagnostic devices placed on the market after July 22, 2016. The directive does not apply to active implantable medical devices.

 

A manufacturer prepares technical documentation demonstrating that design and manufacture of the product satisfies the requirements of the RoHS directive. The manufacturer prepares a declaration of conformity (Annex VI specifies the required elements) and retains both documents for ten years after placing the product on the market.

 

The limits in the directive create maximum concentration value by weight in homogeneous materials. Annex II lists the materials and their limits. Annex IV lists some medical device applications exempt from the restrictions.

Lead 0.1%

Mercury 0.1%

Cadmium 0.01%

Hexavalent chromium 0.1%

Polybrominated biphenyls (PBB) 0.1%

Polybrominated diphenyl ethers (PBDE) 0.1%

 

You can download the directive from the Official Journal at

http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2011:174:SOM:EN:HTML

Harmonized Standards to MDD Updated

The EU updated the list of MDD Harmonized Standards on May 13, 2011.

 

The two most commonly cited standards did not change.

EN ISO 13485:2003/AC:2009 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

EN ISO 14971:2009 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

 

Some of the items marked new include:

EN ISO 8835-3:2009/A1:2010 Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007)

 

EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates

 

EN 60601-2-52:2010 Medical electrical equipment – Part 2-52: Particular requirements for basic safety and essential performance of medical beds (IEC 60601-2-52:2009)

 

The list of harmonized standards is available at http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/medical-devices/index_en.htm

Health Canada Issues Three New Guidance Documents

Health Canada issued three new guidance documents in June 2011.

·        Guidance Document For The Interpretation Of Significant Change

·        Guidance Document: Information to Be Provided by Manufacturers for the Reprocessing and Sterilization of Reusable Medical Devices

·        Guidance On The Content Of Quality Management System Audit Reports

 

You can download the documents from http://www.hc-sc.gc.ca/dhp-mps/md-im/update-miseajour/index-eng.php

 

The significant change guidance uses a series of flow charts to help the user classify changes. The guidance document has a main flowchart that leads to others as listed below.

 

Main Flowchart: General changes made to devices

Flowchart A: Changes in manufacturing processes, facility or equipment

Flowchart B: Changes in manufacturing quality control procedures

Flowchart C: Changes in design

Flowchart D: Changes to sterilization

Flowchart E: Changes to software

Flowchart F: Changes in materials for non in vitro diagnostic devices (IVDDs)

Flowchart G: Changes in materials for IVDDs

Flowchart H: Changes to labeling

 

The reusable device guidance explains how the regulations apply to each class of device. The guidance provides a table format, based on CAN/CSA/ISO 17664, for reprocessing instructions.

 

The audit report guidance contains information on the preparation and content of QMS audit reports. This guidance uses work of the Global Harmonization Task force (GHTF) Study Group 4, in particular, SG4/N33R16:2007 Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 3: Regulatory Audit Reports.

 

The guidance also supports the US FDA’s Medical Devices ISO 13485:2003 Voluntary Audit Report Submission Pilot Program.

Article on Risk Priority Numbers Available in the Ombu Library

The Risk Priority Number (RPN) is a method to allocate resources. The article discusses the risk management approach of assigning risk acceptability based on severity and probability. In contrast, the FMECA, a reliability tool, often uses the RPN on a scale of 1 to 1,000. The article explains the role of the RPN and shows that there are only 120 possible values, not the 1,000 as commonly expected.

Dan OLeary Publishes an Article on the Martixx Case

In May of this year, the US Supreme Court handed down a unanimous decision that linked adverse reporting to the FDA with financial reporting. Matrixx had information concerning potential problems with Zicam Cold Remedy, the largest selling product in their line. They didn’t reveal the adverse event information to investors because they didn’t find the information statistically significant. The Court concluded that statistical significance is not the threshold for reporting.

 

The article, published in Cerulean’s Smarter ComplianceTM is available in the Ombu Library. This newsletter is a valuable resource for people involved FDA regulatory issues. I recommend that readers subscribe to this valuable newsletter. To subscribe, send an e-mail to orders@ceruleanllc.com or visit www.ceruleanllc.com.

 

Readers may recognize Cerulean by its association with John Avellanet and his influential book Get To Market Now! This book, describing the methods you need to help turn FDA compliance into a competitive edge, belongs in the “most frequently read” section of your book shelf.

GHTF Issues a New Guidance on a Regulatory Model

The Global Harmonization Task Force (GHTF) issued a new guidance document on a regulatory model. The guidance diagrams a model, from a few different views, and shows how the guidance documents from the GHTF’s Study Groups fits into the model. While starting with a simple life-cycle model for devices, the guidance refines it into a more comprehensive approach, showing how each GHTF Study Group’s documents fit into the refined model.

 

The document includes tables that delineate the role and responsibility of some stakeholders in the regulatory system, i.e., manufacturers, regulators, and conformity assessment bodies. The guidance also includes a bibliography of GHTF and ISO documents that factor into the regulatory scheme.

 

Readers may obtain the document from the GHTF website (www.ghtf.org) or from the Ombu Library.

FDA Launches Basics for Industry Website

In January 2011 the FDA launched a new website, “to help companies and others save time and resources in their interactions with the agency.” The new website is available at http://www.fda.gov/ForIndustry/FDABasicsforIndustry/default.htm

 

The U.S. Food and Drug Administration today introduced a new Web resource called FDA Basics for Industry to help companies and others save time and resources in their interactions with the agency. The website includes basic information about the regulatory process, including information that industry frequently requests.

 

The website is part of the transparency initiative and is one of the 19 action items listed in the FDA’s report titled “FDA Transparency Initiative: Improving Transparency to Regulated Industry.”

 

The menu bar, at the left of the opening page has the following selections:

About FDA

Guidances

Registration and Listing

Regulatory Process

Product Application and Petition Review Process

Stay Informed

Search Databases

Popular Content

Frequently Asked Questions

Educational Resources

FDA Issues New List of Recognized Consensus Standards

On March 14, 2011 the FDA issued Updated Recognition List #26. Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements.

 

This new recognition list updates previous recognitions and identifies other standards recognized for the first time.

 

The announcement breaks the recognized standards into the categories listed below.

 

Anesthesia
Biocompatibility
Cardiovascular
Dental/ENT
General
General Hospital/General Plastic Surgery
IVD
Materials
Nanotechnology
OB-GYN/Gastroenterology
Ophthalmic
Orthopedics
Physical Medicine
Radiology
Software/Informatics
Sterility
Tissue Engineering
 
The list is available at http://www.gpo.gov/fdsys/pkg/FR-2011-03-14/html/2011-5815.htm
Harmonized Standards to MDD Updated

The EU updated the list of MDD Harmonized Standards on January 18, 2011.

 

The two most common standards did not change.

 

EN ISO 13485:2003/AC:2009 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

 

EN ISO 14971:2009 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

 

The EU publishes the list at http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/medical-devices/index_en.htm http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/medical-devices/index_en.htm

Health Canada Releases Draft Guidance on QMS Audit Reports

Health Canada released a draft guidance document on the content of QMS audit reports. The document is open for comments until March 8, 2011. The document provides guidance to Health Canada recognized registrars on the content of quality management system (QMS) audit reports.

 

This guidance document uses the work of Study Group 4 of the Global Harmonization Task Force (GHTF), and in particular on the technical content of GHTF document SG4/N33R16:2007 Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 3: Regulatory Audit Reports.

You see the announcement, learn how to comment, and get a PDF copy of the draft guidance at http://www.hc-sc.gc.ca/dhp-mps/consultation/md-im/draft_ebauche_md_im_gd211-eng.php

New MEDDEV Documents on Clinical Investigations Published

The European Commission issued two new guidance documents on Clinical Investigations. MEDDEV 2.7/4 provides Guidelines on Clinical Investigations: A Guide for Manufacturers and Notified Bodies.

 

The basis for the guidelines SG5/N3:2010 Clinical Investigations posted on April 26, 2010 (see www.ghtf.org). The MEDDEV guidance is adapted to the requirements in Annex X of the Medical Device Directive (MDD). A manufacturer should conduct Clinical Investigation following the guideline. A clinical investigation, in MEDDEV 2.7/4, is “any systematic investigation or study in or on one or more human subjects, undertaken to assess the safety and/or performance of a medical device.” (SG5/N1:2007)

 

MEDDEV 2.7/3 Clinical Investigations: Serious Adverse Event Reporting provides information on reporting adverse events occurring in clinical investigations. The website also provides an Excel form for reporting.

 

You can download these new guidance documents at http://ec.europa.eu/consumers/sectors/medical-devices/documents/guidelines/

Health Canada Provides New Information on Software as a Medical Device

In December 2010 Health Canada added some new information on how it regulates software that is a medical device. The Notice says, “Software that is intended or represented for use in the diagnosis or treatment of an abnormal physical state of a patient meets the definition of a medical device under the Food and Drugs Act and must therefore comply with the requirements of the Medical Devices Regulations.”

 

The two documents, posted on Dec. 12, 2010, are:

Software Regulated as a Medical Device - Frequently Asked Questions

Notice - Software Regulated as a Class I or Class II Medical Device

 

You can read the documents on the Health Canada website

http://www.hc-sc.gc.ca/dhp-mps/md-im/update-miseajour/index-eng.php

QSR Changes Document Added to the Ombu Library

The Ombu Library has a new document, in the Medical Device Regulations section, that lists the changes to FDA’s Quality System Regulation. FDA issued the final rule on Oct. 7, 1996. Since then, QSR changed seven times. FDA has changed only three sections since they issued the final rule:

21 CFR §820.1 Scope

21 CFR §820.198 Complaint files

21 CFR §820.200 Servicing

 

The summary identifies the sections affected, lists the changes, and provides the citation in the Federal Register.

GHTF Issues New Guidance Document on Corrective and Preventive Action

The Global Harmonization Task Force (GHTF) is a voluntary international organization that supports harmonization of medical device regulations around the world. GHTF has five study groups, who issue guidance documents. Study Group 3 (SG3) covers issues related to Quality Systems.

 

The new guidance, Quality Management Systems – Medical Device – Guidance on Corrective Action and Preventive Action and Related QMS Processes id dated Nov. 2010 and is the final version of the document.

 

The document doesn’t use the acronym “CAPA” since “the concept of corrective action and preventive action has been incorrectly interpreted to assume that a preventive action is required for every corrective action.”

 

The guidance partitions the corrective action and preventive action processes into four phases: Planning, Measurement and Analysis, Improvement, and Input to Management. The guidance illustrates each phase and the linkages with an overview diagram. In addition, the guidance each phase and it constituent processes.

 

In Phase I, Planning, the manufacturer specifies the processes and resources needed to meet the objectives. This phase plans for measurements and analysis and establishes data sources.

 

Phase II conducts measurement, monitoring, and analysis to determine conformity and nonconformity.

 

Phase III, the Improvement phase helps mitigate or eliminate the cause of a detected or potential nonconformity. This phase uses a six step process:

1. Investigate

2. Identify Root Cause

3. Identify Actions

4. Verification of Identified Actions

5. Implement Actions

6. Determine Effectiveness of Implemented Actions

 

Phase IV reports to Management. The Management Review helps management ensure the overall QMS is effective.

 

You download this GHTF guidance document, at no charge, from www.ghtf.org/sg3/sg3-final.html. The GHTF web site is www.ghtf.org which gives access to the documents from all the Study Groups.

Potential Updates to ISO 13485

At a recent FDA News conference I asked Kimberly Trautman, FDA’s expert on QSR, if FDA has any plans to update QSR based on the changes to ISO 9001 and ISO 13485. QSR dates from the element approach (in ISO 9001:1994), but the ISO standards now employ the process approach. Her answer surprised me. FDA may consider updating QSR after the next round of changes to ISO 9001 and ISO 13485. She explained that ISO plans extensive changes in 9001 for 2014 or 2015. Moreover the new version of 13485 must reflect the changes in 9001. She said that the 9001 changes may include many of the techniques employed in the automotive industry, meaning that will also be in a subsequent 13485 revision and applied to the medical device industry.

 

The planning process for ISO 9001 is underway. ISO/TC 176, who is responsible for ISO 9001, is soliciting input with a survey. Recognizing the link between 13485 and 9001, you should take the survey. The link is http://isotc.iso.org/livelink/livelink/fetch/2000/2122/-8835176/-8835848/8835872/8835883/9841934/customview.html?func=ll&objId=9841934&objAction=browse

 

While the survey is broad it asks some very interesting questions. One relates to format and asks the respondent about the format. The choices are:

 

Option A - Leave ISO 9001 unchanged – re-confirm “as-is” for a future five years (to approximately 2018).

 

Option B - Revision of ISO 9001 - based on the suggestions for change given in this survey, produce one revised ISO 9001 standard, where all requirements remain equally mandatory.

 

Option C - Leave ISO 9001:2008 unchanged but also develop another standard with an enhanced (higher level) set of Quality Management System requirements for sustained success that can be used for certification/registration.

 

Option D - Leave ISO 9001:2008 unchanged but also develop another standard with a reduced (lighter version) set of requirements that can be used for certification/registration of organizations providing low-risk products.

 

Option E - Replace ISO 9001:2008 with a series of three documents (Quality Management System 1, Quality Management System 2, Quality Management System 3) with higher, middle and lower set of requirements that can be used for certification/registration depending on the risk and criticality associated with the organization’s products.

 

Option F - Replace ISO 9001:2008 with a single standard, that would include a much broader range of higher and lower sets of requirements, allowing organizations a greater choice depending on risk and criticality associated with the organization’s products.

 

Option G - Replace ISO 9001:2008 with a single standard including a full range of higher, middle and lower sets of requirements, with points-based maturity assessment.

 

In addition, there is a question about the techniques to include. The choices here are:

  • Supporting Quality Tools (for example Six Sigma, Lean, Statistical Process Control)
  • Financial resources of the organization
  • Innovation
  • Integration of Risk Management
  • Knowledge Management
  • Life Cycle Management
  • Strategic Planning
  • Measures (examples are performance, satisfaction, return on investment) Measures (examples are performance, satisfaction, return on investment)
  • Systematic problem solving and learning
  • Voice of the Customer
  • Use of technology to develop and implement the requirements of the standard
  • Use of technology to run your business
  • Self-assessment tool

 

The survey gives a link to an explanation of the concepts.

http://isotc.iso.org/livelink/livelink/fetch/2000/2122/138402/755901/1069636/8579854/customview.html?func=ll&objId=8579854&objAction=browse&sort=name

 

Paper on QSR Definitions of component and manufacturing material

FDA’s QSR defines two terms that often confuse practitioners: component and manufacturing material. QSR defies these terms but confusion continues. This Ombu paper explains these terms and others as well. The broad term “product includes five things: component, manufacturing material, in=process device, finished device, and returned device. The paper discussed each of them and explains the differences and the requirements for each one.

 

You can read the paper Understanding Product in FDA’s QSR in the Medical Device Regulations section of the Ombu Library.

CDRH Offers Two New Courses in the CDRH Learn Series

CDRH offers courses in medical device topics at their website http://www.fda.gov/Training/CDRHLearn/default.htm

 

CDRH recently added two news courses:

Export Certificates for Medical Devices

Medical Device Reporting (MDR)

 

The MDR course includes separate modules on:

MAUDE - Information Available to the Public

Electronic Medical Device Reporting (eMDR)

Medical Device Reporting

MDR for User Facilities

MDR for Manufacturers and Importers

 

All of the courses offer a video program or just the slides to download. Many of the courses also offer a post course test to help you evaluate your learning.

Canada Allows E-Labeling of Certain Medical Devices

Canada recently published a clarification of device labeling. The new approach applies only to devices not sold to the general public.

 

The manufacturer may provide electronic labeling on a Compact Disc (CD) or Digital Video Disc (DVD), that accompanies the device at the time of sale and/or delivery. The CD or DVD must be packaged with or accompany the device in a manner that alerts the user to its purpose. The information provided on the CD or DVD should be easily navigable.

 

In addition, for Class IV devices and in vitro diagnostic devices (IVDD) that are not near patient IVDDs may provide the labeling information on the internet. The devices must include the internet address and be displayed to alert the user.

 

You may find more information at http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/announce-annonce/md_e-labelling_im_etiquetage_electronique-eng.php

A Paper on Statistical Tolerancing Added to the Ombu Library

A new paper on statistical tolerancing is new in the Ombu Library. This paper explains some basic concepts of statistical tolerancing and contrasts the method with worst case analysis.

 

The simplifying assumptions include a normal distribution and a Cpk = 1.00 for both the parts and the final assembly. The paper explains the method to combine normal distributions to model the resultant distribution.

CDRH Ends Pilot Audit Program with Canada

CDRH recently announced the completion of a pilot program with Health Canada (HC) to perform joint inspections.

 

The pilot inspected 10 companies, who volunteered for the program. The inspectors were in the FDA’s Accredited Persons (AP) program and HC’s Canadian Medical Devices conformity Assessment System (CMDCAS). One of the pilot project’s goals was to determine the potential for time savings in the inspection process. This would benefit FDA, HC, and the site under investigation. The pilot showed savings of about 35% in person-days to conduct the inspection.

 

The final joint report, available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ThirdPartyInspection/ucm232806.htm, describes the results of the project.

 

The final report lists findings and recommendations. We describe a few of them below.

 

The activity types should align. The activity should pair HC surveillance with FDA Level 1; pair HC re-assessment and FDA Level 2.

 

Nonconformity responses didn’t contain a cause analysis, a clear statement of the correction, or a clear statement of the corrective action. As a result, both HC and FDA intend to train inspectors using the Global Harmonization Task Force guidance GHTF/SG3/N18 “Quality management system – Medical Devices – Guidance on corrective action and preventive action and related QMS processes”. See www.ghtf.org.

 

Reports varied in description, level of detail, and format. They varied in length from 3 to 20 pages. FDA and HC are collaborating on a single report format developed in HC “GD 211: Guidance on the content of quality management system audit reports”.

CDRH lists proposed documents for FY11

Each year CDRH publishes a list of proposed new documents for the upcoming fiscal year. CDRH published the FY11 list on Oct. 6, 2010.

 

Some the proposed documents are in the list below.

 

Guidance on Postmarket and Compliance Issues

Medical Device Reporting for Manufacturers

"510k Actions"-FDA and Industry Actions on Premarket Notification Submissions

Research Use Only

Distinguishing Medical Device Enhancements from Product Recalls and Corrections

Electronic Medical Device Reporting

 

Global Harmonization or Standards Related Guidances

Global Harmonization Task Force: Quality Management System; Process Validation

Global Harmonization Task Force: Post Market Surveillance; National Competent Authority Report Exchange Criteria and Report Form

Application of IEC 60601-1 Third Edition

Medical Device ISO 13485

 

Cross-Cutting, Process, and Other Guidances

Radio-Frequency Wireless Technology in Medical Devices

Quality Systems for Laboratory Developed Tests

Medical Device Home Use

 

You may view the complete list at  http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109196.htm

 

Canada Proposes GHTF STED based Class III and Class IV Premarket Medical

Health Canada issued the draft guidance for comment. This guidance, for Class III and Class IV devices, uses the Global Harmonization Task Force (GHTF) approach to documentation.

 

The GHTF developed the Summary Technical Documentation (STED) approach to encourage and support convergence of regulatory systems for medical devices among jurisdictions. Health Canada has adopted use of the STED for premarket license applications and license amendment applications for Class III and Class IV medical devices. Although the use of the STED is not mandatory, Health Canada strongly encourages manufacturer’s to follow this guidance when submitting Class III and IV medical device license applications and amendment applications.

 

The comment period ends on December 12, 2010.

 

You can obtain a copy of the draft guidance and information on submitting comments at http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/consultation/md-im/md_draft_gd_im_ebauche_ld_sted-eng.pdf

 

GHTF Posts New Guidance Documents on Auditing

The Global Harmonization Task Force (GHTF) published two new guidance documents in their quality auditing series.

 

GHTF/SG4/N83:2010 is part 4 and deals with Multiple Site Auditing

 

GHTF/SG4/N84:2010 is part 5 and deals with Audits of Manufacturer Control of Suppliers

 

Both documents are available at no charge from www.ghtf.org.

 

The final documents in the series cover the following topics.

Part 1: General Requirements

Part 1 Supplement 2: Training Requirements for Auditors

Part 2: Regulatory Auditing Strategy

Part 3: Regulatory Audit Reports

Part 4: Multiple Site Auditing

Part 5: Audits of Manufacturer Control of Suppliers

FDA (CDRH) Announces Total Product Life Cycle (TPLC) Database

The Total Product Life Cycle (TPLC) database integrates premarket and postmarket data about medical devices. It includes information pulled from CDRH databases including Premarket Approvals (PMA), Premarket Notifications (510[k]), Adverse Events, and Recalls. The TPLC database is refreshed as each of the individual data sources is updated.

 

The TPLC database description is at http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHTransparency/ucm199906.htm

 

From this link, the user can move to the search page where you can search the TPLC database by device name, product code (the 3 letter code for each device), or regulation number. The search provides a full report about a particular product line.

CDRH Creates an Inspections Database

CDRH announced a database for certain inspections. The inspections in the database are limited to those for which CDRH had direct involvement. In general, FDA’s Office of Regulatory Affairs (ORA) conducts device inspections. CDRH becomes involved in inspections such as foreign inspections, Medical Device Reporting (MDR) malfunction issues, labeling, and software issues.

 

You can search the Inspection database by Company Name, Country, Medical Specialty, Inspection Type, Product Code, Inspection Classification, Inspection Action, District, or Date. The database has the following URL.

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTPLC/inspect.cfm

Medical Device Risk Management slides added to the Ombu Library

This program introduces the concepts of Risk Management in ISO 14971:2007. It explains the flow of information from the Risk Management Plan to the Risk Management Report. It covers the differences among Hazard, Harm, and Risk and explains how to evaluate each of them. The program describes development of a Risk Evaluation Matrix taking into account the probability of occurrence and the severity of the harm. The standard requires a list of known and foreseeable hazards as well as foreseeable sequences of events that could result in harm. The presentation describes the tools (FMEA, FTA, and HAACP) and their application.

Slides on comparative analysis between ISMs CPSM and APICS CSCP added to the Ombu Library

Both ISM and APICS offer certifications in Supply Chain Management. The ISM certification is Certified Professional in Supply Management (CPSM). The APICS certification is Certified Supply Chain Professional (CPSC). Ombu performed a comparative analysis between the certifications including requirements to take the exam, exam content, total certification cost, and certification maintenance. Ombu presented the analysis to NAPM-NH as part of a workshop on professional certification.

Equipment Utilization Article added to the Ombu Library

One of the issues in Total Productive Maintenance (TPM) is the calculation of equipment utilization. This article explains the calculation using the standard method developed in the TPM literature. However, it offers a much more intuitive explanation by explicitly looking at time as the measurement parameter. Look for this article in the Total Productive Maintenance section.

MEDEV 2.4/1 Classification of Medical Devices revised

The European Union publishes guidance documents for medical devices. These guidance documents provide valuable information for companies that supply medical devices subject to the Medical Device Directive (MDD), 93/42/EEC as amended by Directive 2007/47/EC.

 

The EU publishes the guidance documents at http://ec.europa.eu/consumers/sectors/medical-devices/documents/guidelines

 

In June 2010, the EU published revision 9 of MEDEV 2.4/1 Classification of Medical Devices.

 

This document is a revision of an earlier document published in July 2001 as MEDDEV 2.4/1 rev 8. It includes information pertaining to the changes in classification resulting from the amending and implementing Directives issued since the last revision of this document in 2001, including derogation of the classification rules in the case of breast implants and hip, knee and shoulder joint replacements and requirements related to devices containing human blood derivatives and medical devices manufactured utilizing tissues of animal origin. In addition this guidance document takes account of the changes arising from Directive 2007/47/EC which further amends Directive 93/42/EEC and became applicable as from 21st March 2010.

RoHS Q&A added to Ombu Library

Occasionally, firms need information on the EU’s RoHS Directive. Ombu has answered some client questions, and provides a simple Q&A that can help a firm get started.

FDA publishes a Comprehensive List of Guidance Documents

The FDA publishes Guidance Documents, following 21 CFR §10.115, to provide information for stakeholders.

  • Guidance documents are documents prepared for FDA staff, applicants/sponsors, and the public that describe the agencys interpretation of or policy on a regulatory issue.
  • Guidance documents include, but are not limited to, documents that relate to: The design, production, labeling, promotion, manufacturing, and testing of regulated products; the processing, content, and evaluation or approval of submissions; and inspection and enforcement policies.
  • Guidance documents do not include: Documents relating to internal FDA procedures, agency reports, general information documents provided to consumers or health professionals, speeches, journal articles and editorials, media interviews, press materials, warning letters, memoranda of understanding, or other communications directed to individual persons or firms.

 

CDRH staff, regulated industry, and the public prepare Guidance Documents related to:

  • the processing, content, and evaluation of regulatory submissions
  • the design, production, manufacturing, and testing of regulated products
  • the inspection and enforcement procedures

 

FDA published a comprehensive list, organized by Center, in the Federal Register on August 9, 2010.

 

For devices, you can search CDRH guidance documents at

 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm

 

Ombu Comments on Notice of Information Collection for QSR

The US Government’s Paperwork Reduction Act requires Federal Agencies to report collection activities to the Office of Management and Budget for approval and renew the approval every three years.

 

FDA is seeking public comments on the collection activities related to QSR. The FDA published the notice in the Federal Register as Docket Number FDA-2010-N-0273. You can get a copy and offer comments at http://www.regulations.gov/search/Regs/home.html#home

 

FDA estimates that there are 8,924 firms that must collect information, and that the total number of hours to write and maintain procedures, generate records, etc. The Federal Register Notice describes the activities under the various QSR sections and subsections and estimates the hours per record. For example, “Section 820.22 requires the conduct and documentation of [Quality System] audits and reaudits.” FDA estimates that a firm subject to QSR needs 33 hours per year to satisfy section 820.22.

 

Ombu commented on the proposed recording keeping requirements, because we believe the estimates are very low. The notice and Ombu’s comments are in the Ombu Library in the FDA Information Section.

Ombu presents a workshop on Supplier Agreements

Dan O’Leary will present a half-day workshop on supplier agreements at the 2nd Annual Supplier Summit sponsored by FDA News. The workshop is part of the pre-conference activities, and is scheduled for August 18 in Bethesda, MD

 

For information on the conference, see the brochure at

http://www.fdanews.com/conference/detail?eventId=2919

European Commission Opens Consultation on the IVDD

The consultation process seeks public views related to a legislative proposal that addresses:

 

·        Classification of IVDs

·        Conformity assessment procedures applicable to IVDs

·        Scope of IVD types subject to the requirements of the IVD Directive

·        Clinical evidence for IVDs

 

The Ombu Library has a copy of the document that describes the specific issues the commission wishes to address.

 

You should submit comments by September 15, 2010.

 

Submit comments on by mail, fax, or email to:

European Commission

Health and Consumers Directorate-General (DG SANCO)

Unit SANCO B2, Cosmetics and Medical Devices

B-1049 Brussels, Belgium

Fax: 00 32 (0) 2 296 64 67

E-mail: SANCO-IVD-REVISION@ec.europa.eu

 

You can obtain further information from the European Commission website at: http://ec.europa.eu/enterprise/newsroom/cf/itemlongdetail.cfm?item_id=4404&tpa_id=164&lang=en

 

 

Ombu slides presented at the FDAs LDT Meeting

Dan O’Leary made a presentation at the FDA’s Laboratory Developed Test (LDT). The slides are on the Ombu Website in the Library section.

 

Ombu took the position that regardless of the source of the test (IVD test kit or Laboratory Developed Test) the regulatory requirements should be the same; the level playing field argument.

Understanding the Versions of ISO 13485

This note describes two of the many versions of ISO 13485. The first path describes ISO 13485, while the second path describes EN ISO 13485.

 

The ISO Path

In 2003, ISO issued ISO 13485:2003. This standard provides particular requirements for medical devices, using ISO 9001:2000 as a basis.

 

Subsequently, ISO issued ISO 9001:2008 to replace ISO 9001:2000.

 

ISO then issued ISO 13485:2003, Cor. 1 to correct some references in ISO 13485:2003. These references cite ISO 9001 without citing the version. The corrigendum clarifies the references to ISO 9001:2000.

 

The CEN Path

CEN issued EN ISO 13485:2003 as a European Norm. Eventually it became harmonized to the MDD, IVDD, and AIMDD.

 

CEN needed to replace EN 46003 and add references to Module E in several places. These modules define the conformity paths applied by the new approach directives. This change didn’t have any impact on manufacturers. The change became EN ISO 13485:2003/AC 2007.

 

CEN incorporated ISO 13485:2003 Cor. 1 and EN ISO 13485:2003/AC 2007 into EN ISO 13485:2003/AC 2009. This version is harmonized to the MDD, IVDD, and AIMDD.

 

Regards,

Dan

New Revision to Harmonized Standards Related to the Medical Device Directive

The list of standards harmonized to the Medical Device Directive (MDD) now includes the list of July 7, 2010 in the Official Journal.

 

Two standards of particular interest to general medical device practitioners are ISO 13485 and ISO 14971.

 

For ISO 13485, the current version is EN ISO 13485:2003/AC:2009.

 

This version is based on EN ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003) that superseded EN ISO 13488:2000, EN ISO 13485:2000, and EN 46003:1999 on July 31, 2009.

 

For ISO 14971, the current version is EN ISO 14971:2009 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) that superseded EN ISO 14971:2007 on March 21, 2010.

 

One can view the complete list at http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/medical-devices/index_en.htm

Dan OLeary to speak at FDA Meeting on Laboratory Developed Tests

On July 19 & 20, the FDA will sponsor a public meeting on Laboratory Developed Tests (LDTs). The meeting announcement says, “Since the implementation of the 1976 Medical Device Amendments, the FDA has generally exercised enforcement discretion and not enforced applicable regulations with respect to LDTs, a class of in vitro diagnostics (IVDs) that are manufactured, including being developed and validated, and offered, within a single laboratory. Thus, the FDA has not actively regulated most LDTs.”

 

Dan’s presentation will be part of Session 1: Oversight of LDTs: Patient and Clinical Considerations, and will make the case that a level playing field between IVD developers and Laboratories is the best approach for public health in the US. Today, if an IVD manufacturer wishes to bring a test to market, the regulatory requirements are much higher than those experienced by a laboratory introducing the same test.

GxP Lifeline Process Validation Reprint is Available in the Ombu Library

Dan O’Leary’s recently printed article in GxP Lifeline is now available in the Ombu library. This article explains some of the issues in validating medical devices and shows how to employ statistical concepts.

 

The article, “Process Validation for Medical Devices GxP Article” is in the Medical Device Regulations section.

 

Revised Format for MDD Harmonized Standards List

The Medical Device Directive suggests the use of Harmonized Standards to assure a device meets the Essential Requirements. The EU maintains a list of these standards at http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/medical-devices/index_en.htm

 

The list has a new, and easier to use, format. The list clearly identifies new standards with the word (new), colored in red with a note that announces the first publication of a standard.

 

The list, at this writing, includes the information from the Official Journal dated December 2, 2009.

Health Canada Proposes Changes to the List of Recognized Medical Device Standards

On April 19, 2010, Health Canada announced a list of proposed changes to recognized standards for medical device. This announcement started a 60-day comment period. Submit comments to Health Canada no later than June 18, 2010 to an address included in the proposal.

 

The proposed changes

·        Add 22 new standards

·        Recognize new versions of 92 currently recognized standards

·        Delete 31 standards

 

Included in the new versions of currently recognized standards are:

ISO 14971:2007 Medical devices - Application of risk management to medical devices

CAN/CSA-ISO 14971-07 Medical devices - Application of risk management to medical devices

 

The list does not propose any changes for ISO 13485.

 

The list of proposed changes is at

http://www.hc-sc.gc.ca/dhp-mps/consultation/md-im/md_stand_im_norm_prop_lst-eng.php

 

The current List of Recognized Standards is posted at

http://www.hc-sc.gc.ca/dhp-mps/mdim/standards-normes/md_rec_stand_im_norm_lst_2-eng.php

 

 

 

A Guidance Document on Recognition and Use of Standards under the Medical Devices Regulations is posted at

http://www.hc-sc.gc.ca/dhp-mps/md-im/applicdemande/guideld/md_gd_standards_im_ld_normes-eng.php

 

Process Validation for Medical Devices slides added to the Ombu Library

Process validation is an important part of both FDA regulations and ISO 13485. It comes into play when a company cannot, or does not, perform 100% verification of the process output. Typically, process validation is required when the verification is destructive. The trend has shifted, however, to cases where sampling plans verify the process output.

 

This slide deck explains the fundamental requirements for process validation in both FDA QSR and ISO 13485. It explains when a process should be validated, the basic components of a process validation (IQ, OQ, and PQ) and how to write protocols and reports. It includes some FDA Warning Letters to help understand the requirements and explain the current status of the FDA Guidance Document as it relates to medical devices.

Tax Credit for Small Device Firms Supporting Biomedical Research

The Treasury Secretary issued guidance on the new Therapeutic Discovery credit. The program provides a tax credit of up to 50% of qualifying research. Eligible firms can opt for a grant, allowing start-ups not yet profitable to benefit from the program.

 

The program targets research projects with potential to produce new therapies, address unmet medical needs, reduce long-term cost growth, or advance cancer cures. The program also considers projects that create and sustain jobs or help to advance our nation’s competitiveness in life, biological, or medical science.

 

The funds are available on a competitive basis to device makers with 250 or fewer employees that have made qualified investments in qualifying therapeutic discovery projects in 2009 and 2010.

 

You may view the Treasury press release at http://www.treasury.gov/press/releases/tg712.htm

 

FDA Issues Draft Guidance on ISO 13485 Voluntary Audit Program

FDA plans to allow device manufacturers to submit ISO 13485:2003 audit results to the FDA. The program would allow FDA to evaluate the results, conduct a risk assessment, and remove the manufacturer from FDA’s routine work plan for one year.

 

The program implements one of the changes of the Food and Drug Administration Amendments Act of 2007, which allows these voluntary submissions. The law allows voluntary audit report submissions, but requires all repots during the preceding two-year period.

 

The draft guidance document requires submission of the report within 60 days from the last day of the most recent audit. The submission must include all ISO 13485:2003 audit reports issued during the preceding two-year period.

 

Docket number FDA-2010-D-0226 includes the draft guidance document and additional information published in the Federal Register. You can review and download these documents as well as comments from http://www.regulations.gov/search/Regs/home.html#home

Enter the document number in the search box.

 

The comment period on this draft guidance closes on August 18, 2010.

Dan OLeary to speak at NEQC Conference in October

Based on the published schedule, Dan O’Leary will make two presentations at NEQC this year. He will present A Unified Approach to Complaints, Servicing, and FDA Reporting at 9:15 am on October 19. In addition, he will present Excel Spreadsheets and FDA Device Regulations at 3:40 pm on October 20.

 

You can learn more about the NEQC Conference at http://www.neqc.org/conference/58/

FDA Updates list of Consensus Standards

The Federal Food, Drug, and Cosmetic Act allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements. FDA announced Recognition List Number 23 with the addition, withdrawal, correction, and revision of certain consensus standards the agency will recognize for use in satisfying premarket reviews and other requirements for devices. FDA will incorporate these modifications in the list of FDA Recognized Consensus Standards in the agency’s searchable database.

 

The announcement is at http://edocket.access.gpo.gov/2010/2010-10562.htm

 

The list modifies standards in the following areas: Biocompatibility, Cardiology, Dental/ENT, General, In Vitro Diagnostics, Materials, Physical Medicine, Sterility, and Tissue Engineering.

 

The list recognizes new standards in the following areas: Cardiology, In Vitro Diagnostics, Orthopedics, Physical Medicine, and Sterility.

 

An area of interest is the ISO 10993 family of standards on Biological Evaluation of Medical Devices. The table below shows the changes to this recognition status of this family.

 

Standard

Change

ANSI/ AAMI/ ISO 10993-1:2003 Biological Evaluation of Medical Devices--Part 1: Evaluation and Testing  

Title, Extent of recognition, and Relevant guidance

ANSI/AAMI/ISO 10993-3:2003 Biological Evaluation of Medical Devices--Part 3: Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity

Title, Extent of recognition, and contact person

ANSI/AAMI/ISO 10993-5:2009 Biological Evaluation of Medical Devices--Part 5: Tests for in vitro Cytotoxicity

Withdrawn and replaced with newer version

ANSI/AAMI/ISO 10993-6:2007 Biological Evaluation of Medical Devices--Part 6: Tests for Local Effects after Implantation

Title and Extent of recognition

ISO 10993-10:2002 Biological Evaluation of Medical Devices--Part 10: Tests for Irritation and Delayed-Type Hypersensitivity

Extent of recognition, and Relevant guidance

ISO 10993-10:2002/Amd.1:2006(E) Evaluation of Medical Devices--Part 10: Tests for Irritation and Delayed-Type Hypersensitivity AMENDMENT 1

Extent of recognition, and Relevant guidance

ANSI/AAMI/ISO 10993-11:2006 Biological Evaluation of Medical Devices--Part 11: Tests for Systemic Toxicity   

Title, Extent of recognition, and Relevant guidance

ANSI/ AAMI/ ISO 10993-12:2007 Biological Evaluation of Medical Devices--Part 12: Sample Preparation and Reference Materials   

Title, Extent of recognition, and Relevant guidance

 

 

 

Slides on QSR Acceptance Activities added to the Ombu Library

The FDA’s Quality system Regulation (QSR) sets requirements for acceptance activities related to medical device manufacture. The requirements cover three acceptance areas: receiving, in‑process, and final. In addition, QSR has specific requirements for procedures and minimum requirements for record keeping. FDA Warning Letters frequently cite this section of the regulations; it is in the top five sections cited.

 

This presentation explains the regulations and provides guidance on their implementation. We cite the regulations and discuss the FDA’s intent as provided in the preamble to the regulations. We explain the advice offer FDA’s QSR Manual. This guidance helps manufacturers implement the regulations using explanation and sample procedures and forms. The FDA has recommended, in Warning Letters, that manufacturer’s obtain a copy to help them come into full compliance.

 

The presentation concludes with an examination of some Warning Letters. We review some mistakes that manufacturers have made and point out ways to avoid them. We also see a few instances where a Warning Letter does not align with the guidance in the QSR Manual or the QSR preamble.

European Commission makes EUDAMED databank mandatory starting May 1, 2011

The European Commission, in a recent decision, made the EUDAMED mandatory for member states starting May 1, 2011. EUDAMED is a European databank for medical devices that is required by the product directives. For example, the Medical Device Directive (MDD) Article 14a calls for the “Regulatory data in accordance with this Directive shall be stored in a European database accessible to the competent authorities to enable them to carry out their tasks relating to this Directive on a well informed basis.”

 

The European Union maintains information on EUDAMED at http://ec.europa.eu/enterprise/sectors/medical-devices/market-surveillance-vigilance/eudamed/index_en.htm

 

Depending on the applicable directive (MDD, IVDD, or AIMD), EUDAMED contains data on:

  • registration of manufacturers, authorized representatives and devices,
  • data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused,
  • data obtained in accordance with the vigilance procedure, and
  • data on clinical investigations.

 

One of the data requirements includes the use of the Global Medical Device Nomenclature (GMDN). The European standard (harmonized to the MDD and other product directives) EN ISO 15225 "Nomenclature - specification for a nomenclature system for medical devices for the purpose of regulatory data exchange" describes the nomenclature requirements. The current versions are: EN ISO 15225:2000, EN ISO 15225:2000/A1:2004, and EN ISO 15225:2000/A2:2005. GMDN is maintained by the GMDN Agency, http://www.gmdnagency.com

 

EUDAMED is an information exchange between national competent authorities and the Commission and is not publicly accessible.

Slides on Medical Device Calibration Programs added to the Ombu Library

This presentation explains the concepts required for a calibration program that satisfies FDA’s Quality System Regulation (QSR), ISO 13485, and ISO 9001. The presentation defines the concepts of accuracy and precision that describe the measuring equipment’s requirements. It also explains the meaning of traceability. With these concepts, the presentation moves to an analysis of FDA requirements and ISO 13485 requirements.

 

Quality Management Systems (QMS) typically include provisions for the control of inspection, measuring, and test equipment. The QSR requirements are in 21 CFR §820.72 and the ISO 13485/9001 requirements are in Clause 7.6.

 

Implementing these requirements requires attention to detail, accurate records, and effective systems. Manufacturers must understand the requirements so they can develop and implement effective processes and procedures. These procedures must include simple calibration stickers to understanding accuracy and precision.

FDA affirms paperwork burden for sterilization labeling

A company may ship a product in its final packaging to a contract sterilizer. The final packaging declares the product as sterile, but it hadn’t been sterilized yet. This potential violation could result in a misbranded product.

 

FDA regulations (21 CFR §801.150(e)) provide a control mechanism that allows this kind of shipment in interstate commerce. Under §801.150(e)(1), manufacturers and sterilizers may sign an agreement containing the following:

(1) Instructions for maintaining accountability of the number of units in each shipment;

 

(2) Acknowledgment that the devices that are nonsterile are being shipped for further processing; and

 

(3) Specifications for sterilization processing.

 

The parties must keep a copy of the agreement (21 CFR §801.150(a)(2)), for at least two years after the final shipment under the agreement. FDA Inspectors may review these records as part of an inspection.

 

Please review these regulations for the specific details. You can read the regulation at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm

 

Following the Paperwork Reduction Act, the FDA submitted information on the burden required to create and keep the records required by this part of the regulation.

 

FDA estimates that companies involved will generate the {§801.150(e)} records 20 times each year, and that each record will take 4 hours to prepare; this is a cost of 80 hours per year. In addition, the FDA estimates that record maintenance {§801.150(a)(2)} takes 0.5 hours per record; this is a total cost of 10 hours per year.

 

The total cost for these records is 90 hours per year.

Webinar on Acceptance Activities for Medical Devices, 4/23 @ 11am EDT

Dan will present this webinar on April 23, Friday 08:00 AM PDT | 11:00 AM EDT. See http://www.complianceonline.com

 

Acceptance activities should be easy for device manufacturers. As one of the FDA’s most frequently cited sections in Warning Letters, however, there are issues and problems in this area of the regulations. These problems range from simple instances of lack of procedures or acceptance criteria to misapplication of statistical methods.

 

This webinar will clear up the regulatory requirements, and help you plan effective and compliant acceptance activities. We look at the regulations and explain what they mean. In addition, we look at the QSR preamble to help clarify the intent and expectations. By analyzing recent Warning Letters, you can learn from the mistakes of others, and ensure your acceptance activities fully comply with both good practice and the regulatory requirements. The Warning Letter review follows an analysis of the regulations using the QSR preamble and the guidance from FDA’s QSR Manual. We look at the process description and usage of the document.

Medical device excise tax information added to the Ombu Library

The text of the newly enacted medical device excise tax law is now in the Ombu Library. This law, part of the Health Care and Education Reconciliation Act of 2010, defines the excise tax.

 

The tax applies to medical devices for human use, following the definition from the Food, Drug, and Cosmetics Act, except for eyeglasses, contact lenses, hearing aids, and any other medical device the Secretary of the Treasury determines is generally purchased by the general public at retail for individual use.

 

The excise tax applies to the manufacturer, producer, or importer, and is 2.3% percent of the device’s selling price. The tax applies to sales after December 31, 2012.

 

The text is in the Health Care Reform section in a document called Medical Device Excise Tax.

Article on determining the revision level of QSR sections added to Ombu Library

This article, Determining the Revision Level of QSR Sections explains how the FDA maintains sections of the regulation. Unlike standards, such as ISO 9001 or ISO 13485, the FDA changes individual sections. The article explains how to look you the revision history of any section using some tools on the FDA website. It also explains how to get the full text and other information using tools on the Government Printing Office (GPO) website.

Webinar on Unified Approach to Complaints, Servicing, and FDA Reporting on Thursday, April 15, 2010 at 1:00 pm EDT

Dan O’Leary will present a webinar for Compliance Panel on a Unified Approach to Complaints, Servicing, and FDA Reporting. Go to http://www.globalcompliancepanel.com for registration information.

 

This course provides the attendees with the information to implement an effective system for managing and reporting adverse events. We break down the regulatory requirements into plain English, and describe them using common quality tools such as flow diagrams and fault tree analysis. This approach helps you understand the essential parts of the regulations.

 

We provide complete descriptions of the interlocking systems that the FDA requires you to implement. These systems include:

·        Complaint Management

·        Medical Device Reporting

·        Corrections and Removals Management and Reporting

·        Corrective Actions

·        Corrective Action Statistical Analysis

·        Risk Management

·        Service Reports

·        Service Report Statistical Analysis

 

These requirements are spread across multiple parts of the FDA regulations, so they are not always implemented in unison. The presentation unites the systems to make their implementation easier and more effective.

 

You will learn when written procedures are required, when (and how) to name designated individuals, when (and how) to formally designate units, what records you must keep, and when you must report to the FDA.

 

You will see statistical techniques that can be used to analyze corrective actions and service reports. These include histograms, scatter plots, check sheets, Pareto charts, and cause-and-effect diagrams.

 

Because these regulations may also span your organizational structure, this webinar is especially suited for cross functional and cross discipline teams.

Webinar on Statistical Concepts of Process Validation on Friday April 30, at 11:00 AM EDT

Dan O’Leary will present a webinar for Compliance on Line on the statistical concepts that underlie process validation. Go to http://www.complianceonline.com for registration information.

 

Process validation is an important element in medical device manufacturing. This webinar looks at the underlying statistical concepts to perform an effective process validation. The webinar examine elements of the FDA regulations for process validation (21 CFR §820.75) as well as the corresponding requirements in ISO 13485.

 

When you cannot (or do not) fully verified process results by subsequent inspection and test this leads to sampling plans. We discuss the use of attribute sampling plans in this context.

 

When you validate the process with a high degree of assurance, this means your process achieves a certain process capability. We discuss the concepts of process capability, especially the use of Cp and Cpk.

 

Operational Qualification (OQ) explores the parameter space that defines the process and selects challenge points as part of the qualification protocol. This naturally leads to Designed Experiments as the exploratory tool.

 

Lastly, Risk Management (ISO 14971) includes production information. This leads directly to validated processes since these are often the production processes that carry the greatest risk.

 

Background

The FDA’s Quality system regulation requires device manufacturers to validate processes when they don’t fully verify the resulting output. Based on Warning Letters, the FDA expects manufacturers to validate processes when the output check uses sampling instead of 100% inspection.

 

The requirement is to validate the process with a high degree of assurance. This, coupled with the process validation definition that a process consistently produces a result or product meeting its predetermined specifications, leads to a statistical definition. A process that consistently produces a conforming output is capable. This leads to using process capability indices, Cp and Cpk as the goal for a validated process.

 

Designed experiments determine the limits of the parameter space for the process. The same techniques, especially full and fractional factorial experiments, can establish “worst case” conditions that become challenge points for the Operational Qualification (OQ) phase of process validation.

 

Risk Management, as defined in ISO 14971, requires the inclusion of production processes. Processes that require validation have the greatest risk, since they are not fully verified. In addition, they often involve the production process with the greatest risk, such as sterilization.

 

The presentation looks at these aspects of process validation using the unifying approach of a statistical model. Rather than a fundamental examination of how to perform process validation, this seminar covers the tools necessary to use the statistical model.

GHTF issues new guidance on auditing supplier control

GHTF recently posted this proposed guidance document at www.ghtf.org. The document, a member of the series on auditing, covers audits of a device manufacturer’s system to control suppliers.

 

The Global Harmonization Task Force (GHTF) is an international organization that encourages regulatory practice convergence to ensure the safety, effectiveness / performance, and quality of medical devices; promoting technological innovation; and facilitating international trade. GHTF publishes and disseminates harmonized documents on basic regulatory practices.

 

Study Group 4 (SG4) covers work in the area of Quality Auditing. This new draft (Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 5: Audits of manufacturer control of suppliers) joins a series of auditing guidance documents already issued:

 

SG4/N28R4:2008 Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 1: General Requirements

 

GHTF-SG4-(00)3 Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 1: General Requirements – Supplement 2: Training Requirements for Auditors

 

SG4/N30R20:2006 Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 2: Regulatory Auditing Strategy

 

SG4/N33R16:2007 Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 3: Regulatory Audit Reports

 

The proposed guidance also refers to:

 

SG1/N055:2009: Definitions of the Terms Manufacturer, Authorized Representative, Distributor, and Importer

 

SG3/N17:2008 Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained from Suppliers

Excel and QSR slides added to the Ombu Library

When a medical device manufacturer uses an Excel spreadsheet, it must comply with two different parts of the FDA regulations. Following 21 CFR §820.70(i) Automated Processes, the manufacturer must validate the spreadsheets used in production or the quality system, and revalidate them when changes are made. Following 21 CFR Part 11, the manufacturer may also have created an electronic record. Device manufacturers must understand these regulations and the means to ensure compliance.

ASQ CBA BoK Analysis added to the Library

Ombu recently taught a Certified Biomedical Auditor (CBA) course for Granite State ASQ. To help develop the course material, we did a comparative analysis of the CBA Body of Knowledge (BoK) with the Certified Quality Auditor BoK.

Medical Device Classification slides add to the Ombu Library

The Medical Device Classification slide presentation explains the classification system in the US, the EU, following the Medial Device Directive (MDD), the Canadian Medical Device Regulations (CMDR), and the guidance from the Global Harmonization Task Force (GHTF). This is a risk-based approach implemented by regulatory authorities.

GHTF posts new CAPA guidance for comment

The Global Harmonization Task Force (GHTF) has announced the availability of a proposed guidance document on CAPA systems. Proposed by Study Group 3 – Quality Systems it is entitled Quality management system – Medical Devices – Guidance on corrective action and preventive action and related QMS processes. The draft is currently open for comment. You can obtain a copy of the document and the comment forms at www.ghtf.org.

Supplier Quality Agreements information added to the Ombu Library

A presentation on Supplier Quality Agreements based on ISO 9001 is now in the Ombu Library in the “Managing the Supply Chain” section. The presentation, prepared by Dan O’Leary, was the workshop topic at the Jan. 20 NAPM-NH meeting. The presentation is accompanied by a template that user can employ as the basis for a Quality Agreement.

Medical Device Quality Agreements information added to the Ombu Library

A presentation on Quality Agreements for medical device manufacturers is now in the Ombu Library. The presentation, prepared by Dan O’Leary, was made to an FDA News virtual conference and to the Worcester MA section of the American Society for Quality. The presentation is accompanied by a template that user can employ as the basis for a Quality Agreement.

Outsourcing and ISO 9001 Presentation added to the Ombu Library

The presentation on Outsourcing and ISO 9001 is a description of the Outsourcing changes moving from Clause 4.1 to Purchasing (Clause 7.4) to Measuring and Monitoring (Clause 8.2). The addition also includes a reformatted version of the ISO guidance document.

ISO 9004:2009 Is Now Available

ISO issued ISO 9004:2009 Managing for the sustained success of an organization – A quality management approach. According to the ISO website, it is available as of October 30, 2009. The description from ISO says, “ISO 9004:2009 provides guidance to organizations to support the achievement of sustained success by a quality management approach. It is applicable to any organization, regardless of size, type and activity.

 

ISO 9004:2009 is not intended for certification, regulatory or contractual use.”

 

 

Servicing, Complaints, and FDA Reporting Presentation added to the Ombu Library

This presentation describes the methods involved handing complaints. It presents two cases that might arise in dealing with servicing and follows them through the interlinked processes required by the FDA. This includes Complaints, CAPA, Medical Device Reporting, Corrections & Removals, Design Changes, and Risk Management.

 

The information distinguishes between records the manufacturer is required to maintain and reports that must be submitted to the FDA. Reports are characterized by the event that triggers the report, the allowed time to report, and the report’s contents. Records are characterized by the event that creates the record and the record’s contents.

FDA updates the list of recognized consensus standards

The FDA published an updated list of consensus standards on Tuesday September 8, 2009. You may view it at http://edocket.access.gpo.gov/2009/pdf/E9-21609.pdf

 

The summary of the announcement says, “The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled ‘‘Modifications to the List of Recognized Standards, Recognition List Number: 022’’ (Recognition List Number: 022), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.”

A paper on selecting sampling AQLs is available in the Ombu Library

This paper, prepared for Ombu customers, describes two aspects of selecting an AQL for attribute sampling plans.

 

The AQL is the “worst case” process average you, as the customer, are willing to accept from your supplier. The supplier could be either internal or external.

 

The AQL is also a point on the Operating Characteristic (OC) curve. The OC defines the long term probability of accepting lots from various process averages. Traditionally, the AQL is the point with a process average that has a 95% probability of acceptance.

Dan OLeary to speak at NEDG on integrating Service and Complaints in QSR

The New England Discussion Group (NEDG) of ASQs Biomedical Division will hold a one day workshop entitled “Complaints and Beyond” on Thursday, Oct. 15, 2009 at the Conference Center at Waltham Woods. Dan O’Leary is one of speakers, discussion the relation between Servicing, Complaint Management, and FDA reporting (including MDRs, Corrections, and Removals).

FDA Proposes Mandatory Electronic MDRs

The FDA has proposed new rules requiring electronic MDR submissions for device manufacturers. The proposed rules, published in the August 21 Federal Register, are open for comment until November 19, 2009.

 

The proposed rules amend 21 CFR Part 803. In addition, the FDA has developed a draft guidance document that describes how to submit electronic MDRs in the new program called eMDR.

 

Low-volume reporters (few or infrequent reports) can use the CDRH eSubmitter (CeSub) software, to submit one report at a time. With CeSub, you manually enter all the pertinent MDR report information into the CeSub program. The program produces the message needed to transmit the report to FDA. The CeSub program also permits you to print a copy of the submitted report. The CeSub software and instructions for installation are free.

 

High-volume reporters (numerous or frequent reports) can develop an application using the prescribed FDA format to create an electronic MDR submission directly from adverse event information in the reporter’s computer system. The file may contain multiple reports in a single submission.

 

The proposed rules do not change the required timeline for reporting. Events must be submitted within 30 calendar days of the manufacturer’s becoming aware of the event. Events which require remedial action must be filed within 5 working days.

 

The proposed rules may be found at www.regulations.gov under Docket Number FDA–2008–N–0393.

 

The draft guidance document may be found at www.regulations.gov under Docket Number FDA-2008-D-0395.

 

The draft Guidance Document may also be obtained from the FDA at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm175805.htm

 

 

FDA Plans to Speed Enforcement Activity

During a recent speech, the new FDA Commissioner, Dr. Margret Hamburg, announced a plan speed up enforcement activities, i.e., shorten the time from an inspection to a Warning Letter. The plan, scheduled for implementation beginning September 15, 2009, is to issue a Warning Letter for significant violations that may lead to enforcement action without taking into consideration information received after 15 days from the date of the FDA 483 (Report of Inspectional Observations).

 

In the past the FDA has delayed warning letters while it reviews information submitted by the firm. When the firm has made multiple submissions, sometimes over many months, the agency has reviewed them and postponed issuing a Warning Letter as a result. Under the new policy, if the FDA receives a response to the 483 within 15 business days, it will consider the response in the decision to issue a Warning Letter.

 

Information received after 15 business days will be reviewed as part of the response to the Warning letter.

 

You may review the new plan in two places.

  • The Ombu Library contains a copy of the Notice from FDA
  • You can review the official version at www.regulations.gov by entering Docket Number FDA-2009-N-0335.

 

You may read Dr. Hamburg’s remarks: Effective Enforcement and Benefits to Public Health, presented to the Food and Drug Law Institute on August 6, 2009 at

http://www.fda.gov/NewsEvents/Speeches/ucm175983.htm

A paper on useful aids for ISO 9001:2008 is available in the Ombu Library

This paper, prepared for Ombu customers, describes some very valuable, but little know resources that can help you implement ISO 9001. It describes documents in the following areas:

  • Definitions of terms
  • Guidance documents on specific portions of ISO 9001
  • Official interpretations of the standards
  • Guidance documents on auditing Quality Management Systems

 

The paper describes each of these and provides links to the websites. All the referenced documents, except ISO 9000:2005, can be downloaded at no charge.

Corrigenda issued for ISO 9001:2008 and ISO 13485:2003

ISO recently issued corrigenda for these two standards. You can download each of them from the Ombu Library at no charge.

 

For ISO 9001, the changes are:

Table A.1, the Correspondence between ISO 9001:2008 and ISO 14001:2004 is replaced

Table B.1, the Changes between ISO 9001:2000 and ISO 9001:2008, some rows are replaced

 

For ISO 13485 the changes are:

“ISO 9001” is replaced by “ISO 9001:2000” throughout the document

In the bibliography, “ISO 13641” is replaced by “EN 13641”

 

Since both ISO 9001 and ISO 13485 are documents of external origin, a good quality system will have the corrigenda available.

 

 

Dan OLeary to speak at the Supplier Quality Management Congress on medical devices

Dan was invited by FDA News, the conference sponsor, to join an expert panel discussion about the vexing problems of medical device supplier quality. The conference, scheduled for August 20 and 21 in Arlington, VA is “Assuring the Integrity of Drug and Device Raw Materials and Supply Chains”

 

Among the other speakers are Distinguished FDA Faculty:

  • Kimberly Trautman, Medical Device Quality System Expert, Office of Compliance, CDRH, FDA
  • Rick Friedman, Director, Division of Manufacturing & Product Quality, CDER, FDA
Medical Device Manufacturing Seminar Schedule Published

Ombu has published the new schedule for Medical Device Manufacturing Seminars. This family of seminars includes Process Validation, Risk analysis (ISO 14971), and CAPA Systems. To see the schedule and locations, mouse over Seminars and select Schedule. You can also download the registration form.

 

To register, send an e-mail to Seminars@OmbuEnterprises.com or call us at 603-209-0600.

 

We look forward to seeing you at a Seminar.

Management System Methods Seminar Schedule Published

Ombu has published the new schedule for Management System Methods Seminars. This family of seminars includes Internal Management Audits and Effective Management Review. To see the schedule and locations, mouse over Seminars and select Schedule. You can also download the registration form.

 

To register, send an e-mail to Seminars@OmbuEnterprises.com or call us at 603-209-0600.

 

We look forward to seeing you at a Seminar.

Slides on CAPA systems, presented at BosCon 2009, are available in the Ombu Library

Dan O’Leary presented a talk at BosCon 2009 on CAPA systems. The presentation explains the requirements in ISO 9001, ISO 13485, and the FDA QSR, cutting through the confusion often associated with Preventive Action, Correction, and Corrective Action. Building on this clear understanding, the presentation explains how to design and implement effective systems and develops metrics for effectiveness and efficiency. We also explore the relationship that CAPA system has to other systems in the regulations including corrections and removals and management review.

Slides (and spreadsheets) for Acceptance Sampling, presented to the ASQ Worcester Section, are available in the Ombu Library

The Worcester Section of ASQ scheduled a workshop on Acceptance Sampling Dan O’Leary conducted the workshop; his slides are now available in the Library section of OmbuEnterprises.com.

Dan OLeary to contribute to the revised CRE Primer

ASQ has announced a revision of Certified Reliability Engineer Body of Knowledge (CRE – BoK). The revised BoK is scheduled for its first use on the October 2009 exam. The Quality Council of Indiana (QCI), publisher of the CRE Primer, will update this well known and valuable reference book. Dan O’Leary was invited to join the team developing the new material for publication.

Consider outsourcing your internal audit program to Ombu

Quality Management Systems, such as ISO 9001, ISO 13485, and FDA QSR, require scheduled audits. As the economy cools, companies have trouble maintaining the internal audit schedule because fewer resources are available. Outsourcing the process, or at lest part of it, is a major opportunity for cost saving. Using an outside firm, such as Ombu, provides more effective audits at lower overall cost. Your employees focus on the activities that produce revenue, while skilled auditors help identify problems that could cost you money in the future.

 

Please contact us at 603-209-0600 or Dan@OmbuEnterprises.com to discuss your internal audit program and learn how we can help.

Process metric paper added to the Library

We added a new paper describing how to develop and implement process metrics based on the process criteria for efficiency and effectiveness.

Dan OLeary to conduct a workshop on Attribute Acceptance Sampling for the Worcester ASQ on April 16

 

Title: Attributes Acceptance Sampling – Understanding How it Works

 

Abstract: Attribute sampling is a powerful tool in the Quality Engineer’s toolkit. This presentation makes clear how these sampling plans work. We explain how the Operating Characteristic (OC) curve describes lot acceptance and define the key points on the curve. We show how to calculate the curve, illustrating simple methods using Excel. With this background, we examine two popular sampling plans: ANSI/ASQC Z1.4 and c=0. Z1.4 contains single, double, and multiple sampling plans. We show the tradeoff between these plans in terms of risk and cost. The standard also contains switching rules, which can help you reduce inspection costs. We also describe the c=0 plans and compare them with the corresponding Z1.4 plans. These plans have advantages and disadvantages, which are easy to understand by comparing the OC curves.

Slides for ISO 9001:2008 for Purchasing Professionals, presented to NAPM-NH, are available in the Ombu Library

The NAPM – NH Chapter scheduled a workshop on ISO 9001:2008 to educate purchasing professionals on ISO 9001, included the revisions in the 2008 version of the standard. Dan O’Leary will conduct the workshop. His slides are now available in the Library section of the OmbuEnterprises.com.

Statistical Quality Methods Seminar Schedule Published

Ombu has published the new schedule for Statistical Quality Methods Seminars. This family of seminars includes Acceptance Sampling, Statistical Quality Control, and Fractional Factorial Design of Experiments. To see the schedule and locations, mouse over Seminars and select Schedule. You can also download the registration form.

 

To register, send an e-mail to Seminars@OmbuEnterprises.com or call us at 603-209-0600.

 

We look forward to seeing you at a Seminar.

Ombu joins Compliance on Line

Compliance on Line is one of the world’s major providers of on-line training and webinars. Ombu has joined the faculty to provide training on medical device and quality issues. Look at http://www.complianceonline.com/ to see the broad and exciting offerings they provide.

Medical Device Manufacturing Seminar Schedule Published

Ombu has published the new schedule for Medical Device Manufacturing Seminars. To see the schedule and locations, mouse over Seminars and select Schedule. You can also download the registration form.

 

We look forward to seeing you at a Seminar.

FDA extends comment period on process validation guidance

The FDA has extended the comment period on the draft Guidance Document on process validations. The comment period now closes on March 16, 2009. The guidance comes from the following FDA Centers: CDER, CBER, and CVM. It does not cover medical devices, and therefore doesn’t replace the current Guideline on General Principles of Process Validation, dated May 1, 1987. You can view the draft guidance at http://www.fda.gov/CDER/GUIDANCE/8019dft.pdf. You can see the submitted comments at http://www.regulations.gov/search/index.jsp after you enter the document number FDA-2008-D-0559.

Dan OLeary to speak on CAPA Systems for medical devices at BosCon 2009

The presentation, entitled “Preventive Action, Correction, and Corrective Action: From Requirements to Effective Processes” The abstract is, “The presentation explains the requirements in ISO 9001, ISO 13485, and the FDA QSR, cutting through the confusion often associated with these terms. Building on this clear understanding, the presentation explains how to design and implement effective systems and develops metrics for effectiveness and efficiency.”

 

BosCon is scheduled for April 28. You find out more information at http://www.asqboston.org/BOSCON/boscon.htm

FDA Announces a Public Workshop on Unique Device Identification

 

The FDA’s public workshop, on the proposed Unique Device Identification System is scheduled for February 12, 2009 in Gaithersburg, MD. The purpose of the public workshop is to obtain information to help FDA better understand the issues involved in the establishment of a unique device identification system (UDI system) and request comments on this topic.

 

President Bush signed into law an amendment to the Food, Drug, and Cosmetic Act requiring the establishment of a UDI system. Specifically the new section 519(f) states, “The Secretary shall promulgate regulations establishing a unique device identification system for medical devices requiring the label of devices to bear a unique identifier, unless the Secretary requires an alternative placement or provides an exception for a particular device or type of device. The unique identifier shall adequately identify the device through distribution and use, and may include information on the lot or serial number.”

 

You can find more information about the UDI system at http://www.fda.gov/cdrh/ocd/udi/

 

Candidate list for REACH Directive chemicals available

The EU’s REACH Directive limits the amount of certain chemicals included in products imported to the EU. Suppliers of articles that contain substances on the Candidate List in a concentration above 0.1% (w/w) must be able to provide certain information upon request.
You may view the candidate list at http://echa.europa.eu/chem_data/candidate_list_table_en.asp

EU issues new draft RoHS and WEEE Directives

Citing the need to “develop a better regulatory environment, one that is simple, understandable, effective and enforceable”, the EU proposed revisions to the two directives. The proposed RoHS Directive includes medical devices in the scope. The proposed Directive cites products covered by the MDD and by the IVMDD. The list of banned substances is not changed, but four new substances have been identified for priority assessment and possible inclusion on the list of banned substances. You can get more detailed information about the proposals at http://ec.europa.eu/environment/waste/weee/index_en.htm

FDA issues new draft Guidance Document for Process Validation

The FDA issued a draft Guidance Document on process validation for comments and suggestions. The comment period closes Jan. 21, 2009. The guidance comes from the following FDA Centers: CDER, CBER, and CVM. It does not cover medical devices, and therefore doesn’t replace the current Guideline on General Principles of Process Validation, dated May 1, 1987. You can view the draft guidance at http://www.fda.gov/CDER/GUIDANCE/8019dft.pdf. You can see the submitted comments at http://www.regulations.gov/search/index.jsp after you enter the document number FDA-2008-D-0559.

FDA issues new draft Guidance Document on Assay Migration Studies for IVDs

The FDA issued a draft Guidance Document on IVD Assay Migration for comments and suggestions. The comment period closes April 6, 2009. The guidance covers “Class III or certain licensed in vitro diagnostic devices in cases when a previously approved or licensed assay is migrating (i.e., transitioning) to another system for which the assay has not been previously approved or licensed.” However, it may also apply to 510(k) devices where the Replacement Reagent and Instrument Family Policy does not apply and to devices where the transition specific concerns. You can view the draft guidance at http://www.fda.gov/cdrh/oivd/guidance/1660.pdf. You can see the submitted comments at http://www.regulations.gov/search/index.jsp after you enter the document number FDA–2008–D–0642.

 
 
 
 
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