FDA Proposed Rule Would Harmonize U.S. Quality System Requirements for Medical Devices with International Standard

On February 23, 2022, FDA published its long-awaited proposed rule to harmonize its regulations governing current good manufacturing practices (“cGMP”) for medical devices with ISO 13485:2016, the international consensus standard for device quality management systems (“QMS”) used by regulatory authorities in many countries throughout the world. FDA proposes to do this by replacing its Quality System Regulation (“QSR”) codified at 21 C.F.R. Part 820 with a new Quality Management System Regulation (“QMSR”) primarily through incorporating ISO 13485 by reference into the new rule. The proposed rule would also add new provisions to help align ISO 13485 with existing requirements in the federal Food, Drug, and Cosmetic Act (“FD&C Act”) and other implementing regulations.

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Implications for Medical Device Companies

1. Inspection Approach [...]

2. Increased Focus on Risk Management [...]

3. Proposed Effective Date and Implementation Strategy [...]

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