“Preparing for the Transition to the Quality Management System Regulation: Are You Ready?” by Neil O’Flaherty

U.S. Good Manufacturing Practices (GMPs) for medical devices are poised to change. It’s been a minute: The last time they changed was in 1996 — almost three decades ago.

How Are Device GMPs Changing — and When?

On February 2, 2024, the U.S. Food and Drug Administration (FDA) published a final rule in the Federal Register that amended the current Quality System Regulation (QSR) (21 C.F.R. Part 820) to more closely follow the widely used international consensus standard of ISO 13485 (See Medical Devices; Quality System Regulation Amendments, 89 Fed. Reg. 7496 [Feb. 2, 2024]. Federal Register : Medical Devices; Quality System Regulation Amendments.)

This final rule amends the QSR by specifically incorporating by reference the requirements and concepts of ISO 13485 and part of ISO 9000. The exact provisions incorporated by reference are:

• ISO 13485:2016(E) (ISO 13485), Medical devices—Quality management systems—Requirements for regulatory purposes, Third edition, March 1, 2016; and
• ISO 9000:2015(E) (ISO 9000), Quality Management systems—Fundamentals and vocabulary, Clause 3— Terms and definitions, Fourth edition, September 15, 2015.

The final rule also amends the title of the QSR to “Quality Management System Regulation” (QMSR). The final rule takes effect February 2, 2026.

Learn more here.