January 31, 2024

FDA’s QMSR Final Rule Issued

FDA has issued its Final Rule on its new Quality Management System Regulation (QMSR) amending its device current good manufacturing practice (CGMP) requirements of the 1996 Quality System (QS) regulation (21 CFR Part 820) to harmonize and modernize it primarily by incorporating by reference ISO 13485:2016 3rd Ed., March 1, 2016, but with additional requirements and conforming edits to clarify the device CGMP requirements.  The Final Rule is scheduled to be officially published in the Federal Register this Friday, February 2, 2024.  It will have a generous two-year transitional period whereby the Final Rule becomes effective on February 2, 2026.

The Final Rule contains FDA’s formal responses to 83 comment groups. For those of us who had already performed gap assessments using the Proposed Rule, here is a summary of the changes between the Proposed Rule and the Final Rule:

• Various non-substantive clarifications that won’t impact the gap assessments performed by my firm

• More broadly citing (but not changing) the FD&C Act’s existing adulteration basis for refusal of entry of foreign devices

• Vocabulary

• Adding additional parameters to be met for granting of a statutory variance(s)

• More prescriptive complaint handling and records

• Packaging and labeling controls adjusted (to prevent, among other things, mixups rather than errors, and to allow inspection any time before use rather than immediately before use)

Remember that the foregoing explanation compares the QMSR Proposed Rule to the QMSR Final Rule.  It doesn’t compare the current outgoing Part 820 (which the remains in effect through Feb. 1, 2026) to the QMSR Final Rule.  Stay tuned for that ultimate comparison.