FDA’s Final Device Manufacturing Rule—Not Quite Harmonious With Status Quo

Lexology March 20, 2024
Jones Day

Amending prior requirements, medical device manufacturers and importers have two years to comply with FDA’s Quality Management System Regulation final rule, a similar approach to prior good manufacturing practices but with several notable changes.

The Food and Drug Administration (“FDA”) finalized the Quality Management System Regulation (“QMSR”) rule in February, amending current device good manufacturing practice requirements of 21 C.F.R. Part 820, Quality System Regulation (“QSR”). The final rule incorporates by reference the international consensus standard used by significant regulatory authorities outside the United States, ISO 13485:2016 and Clause 3 of ISO 9000:2015. The final rule is substantially similar to the proposed rule and does not fundamentally change the requirements for an effective quality system. Notable provisions include:

• QMSR...

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