Regulatory Focus™ > News Articles > Updated List of Recognized Medical Device Standards Released By FDA

Updated List of Recognized Medical Device Standards Released By FDA

Posted 19 March 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) published an updated list of FDA-recognized medical device standards, aiming to "assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices."

Under the 1997 Food and Drug Administration Modernization Act (FDAMA), FDA is authorized to recognize consensus standards developed by national and international organizations. The list was last updated in August 2011, and the most recent iteration marks the 28th update since the list was firm published in 1998.

FDA's list, published 16 March, includes updated contact information, updated standards, reaffirmed standards, new standards with transition periods, withdrawn standards, limits on the recognition of standards and editorial changes.


Read more:

Federal Register - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 028


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