Ombu Enterprises LLC Ombu Enterprises LLC   
 
 
 
  Recognition List #49

In an update to the list of recognized standards (Recognition List #49) FDA-CDRH consolidated many listings under one number when the standards are equivalent. For example, ISO 14971:2007 and ANSI AAMI ISO 14971:2007/(R)2010 both have recognition Number 5-40.

 

In addition, the recognition list changes the status of some standards. Among those in the 10993 family are:

Withdrawn – ANSI/AAMI/ISO 10993-4:2002/(R) 2013 & A1:2006/(R)2013 Biological evaluation of medical devices—Part 4: Selection of tests for interaction with blood [Including AMENDMENT 1 (2006)]

 

Withdrawn – ANSI/AAMI/ISO 10993-6:2007/(R)2014 Biological evaluation of medical devices—Part 6: Tests for local effects after implantation

 

Withdrawn and replaced with newer version – ISO 10993-16 Third edition 2017-05 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables

 

Withdrawn – ANSI/AAMI/ISO 10993-16:2010/(R)2014 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables from medical devices

 

The list does not have any new entries in the Quality Systems/Risk Management (QS/RM) or Electrical Safety/Electromagnetic Compatibility (ES/EMC) categories.

 

Recognition List #49 is available at https://www.federalregister.gov/documents/2018/06/07/2018-12222/food-and-drug-administration-modernization-act-of-1997-modifications-to-the-list-of-recognized

 

 

 

 

 
 
 
 
© 2018 All Rights Reserved.