FDA Implements Quality Management System Regulation for Medical Devices

The Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has implemented the Quality Management System Regulation (QMSR), which updates current good manufacturing practice (CGMP) requirements for medical devices under 21 CFR Part 820. The agency published a final rule in the Federal Register on Monday.

The QMSR incorporates by reference ISO 13485:2016, the international standard for medical device quality management systems developed by the International Organization for Standardization. The change aligns FDA’s regulatory framework with internationally recognized standards and reduces burden on regulated industry. The agency also noted that, should any clause of ISO 13485 conflict with any provision of the FD&C Act and its implementing regulations, the FD&C Act and/or its implementing regulations will control, preserving FDA’s statutory oversight under U.S. law.

The regulation applies to manufacturers of finished medical devices intended for commercial distribution, including certain device accessories. Some devices remain exempt from CGMP requirements (21 CFR 862–892), but manufacturers are still required to maintain complaint files and comply with applicable recordkeeping requirements.

FDA has also updated its device inspection approach. As of Monday, the agency discontinued use of the Quality System Inspection Technique and related inspection programs and began using the revised Inspection of  Inspection of Medical Device Manufacturers Compliance Program (7382.850), which is aligned with the QMSR and ISO 13485:2016.

FDA also withdrew two guidance documents focusing on design control guidance for medical device manufacturers (March 1997) and the review and inspection of premarket approval application manufacturing information and operations (January 2008).