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New Quality Management System Regulation (QMSR) Final Rule - 21 CFR Part 820

The U.S. Food and Drug Administration (FDA) recently announced a significant development in medical device manufacturing regulations. On February 2, 2024, the FDA issued a final rule aimed at harmonizing current good manufacturing practice (cGMP) requirements for medical devices with ISO 13485:2016, the internationally recognized standard for device quality management systems used by regulatory authorities worldwide.

The updated regulations, now known as the Quality Management System Regulation (QMSR), reflect the FDA's determination that the requirements outlined in ISO 13485:2016 align closely with the existing Quality System Regulation (QSR) in 21 C.F.R. Part 820. This alignment ensures a similar level of assurance regarding device safety, effectiveness, and compliance with the Federal Food, Drug, and Cosmetic Act (FDCA).

Key Points:

  1. Transition Period: The QMSR will become effective on February 2, 2026, providing a two-year transition period for device manufacturers.
  2. Scope: The QMSR applies exclusively to manufacturers of finished devices.
  3. Terminology Changes: Adoption of ISO 13485:2016 leads to elimination of QSR-specific terms.
  4. Inspection Updates: Management reviews and quality audit reports will no longer be exempt from FDA inspection.
  5. Flexibility: Some differences between QSR and ISO 13485 may allow for more flexibility under the QMSR.
  6. Retained Requirements: Certain QSR provisions will be retained in the QMSR.
  7. MDSAP: FDA may accept MDSAP audit reports as substitutes for routine inspections.
  8. ISO 13485 Certificates: FDA will not accept ISO 13485 certificates as substitutes for FDA inspections.
  9. Implementation Challenges: U.S. manufacturers without prior ISO 13485 experience may face challenges in adjusting to the QMSR requirements.
  10. Inspection Procedures: Details regarding inspection procedures and implementation remain unclear.

Overall, the transition to the QMSR marks a significant step towards harmonizing medical device quality management systems with international standards, aiming to streamline regulatory processes and enhance global competitiveness. However, clarifications and guidance from FDA regarding inspection procedures and practical implementation are essential for manufacturers navigating the transition effectively.