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  FDA Issues Interoperable Medical Devices Final Guidance Document

On September 6, 2017, FDA-CDER & CBER issued a final guidance document entitled Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.


The guidance document defines an interoperable medical device as a device with the ability to exchange and use information through an electronic interface with another medical product or non-medical product.


During the design phase the guidance recommends applying these considerations to the interface:

·         Purpose of the electronic interface

·         The anticipated users

·         Risk management

·         Verification and validation

·         Labeling considerations

·         Use of consensus standards


Pre-market submission should include:

·         A device description

·         Risk analysis

·         Verification and validation

·         Labeling


The Federal Register announcement says that FDA recognizes that it would take up to 60 days to put the guidance document in place. Pre-market submissions for interoperable medical devices made after 60 days should include the information covered by the guidance.


FDA plans to hold a webinar on the guidance document on October 26, 2017.

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