News about GMP/cGMP


FDA: Proposal to align ISO 13485 with 21 CFR Parts 4 and 820

FDA: Proposal to align ISO 13485 with 21 CFR Parts 4 and 820

The US FDA is proposing to amend the cGMP requirements of the Quality System Regulation for medical devices, namely the 21 CFR Parts 4 and 820. Finally, the ISO 13485:2016 should be incorporated in the US Quality System, by reference. This proposal comes four years after the US FDA announced its willingness to align the two systems.

In the 52-page Federal Register Notice it is proposed

  • to withdraw the requirements in the current Part 820, except for the scope of the current regulation, which should be retained
  • to retain and modify several terms and definitions
  • to amend the title of the regulation and add FDA-specific requirements and provisions that clarify certain concepts used in ISO 13485
  • to implement conforming edits to Part 4 on combination products, while these edits would not impact the cGMP requirements for combination products.

The final regulation will be referred to as the "Quality Management System Regulation (QMSR)" and is definitely another step forward to better international harmonization. Manufacturers holding an ISO certificate of conformance will still be inspected by the FDA and the FDA will not issue any such certificates for ISO 13485.

As there is a greater emphasis on risk management activities in ISO 13485, the FDA points out, that the agency also expects manufacturers integrated risk management activities throughout QMS and across the total product lifecycle.

Once the final rule is published, device makers should be given one year to adapt to the new requirements.The document is open for comments for the next 90 days.


FDA: Federal Register Notice