Medical Device Companies Take Note: FDA’s Proposed Rule to Align ISO 13485 With its Quality System Regulation Moves Forward

Feb 07, 2022

Posted by Sidley Austin

On January 5, 2022, the U.S. Office of Management and Budget (OMB) received the long-awaited proposed rule from the Food and Drug Administration (FDA) that aims to harmonize FDA’s medical device Quality System Regulation (QSR) under 21 CFR Part 820 with International Organization for Standardization (ISO) 13485, the international standard for medical device quality management systems.Continue reading 


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