In the prepublication edition of the Federal Register, the proposed rule on revisions to the Quality System Regulation was published today and may be found here.  According to the notice, the Agency “is proposing to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation to align more closely with the international consensus standard for devices by converging with the quality management system (QMS) requirements used by other regulatory authorities from other jurisdictions (i.e., other countries).”

The FDA further states that it “is proposing to revise its device CGMP requirements as set forth in the QS Regulation, codified in part 820 (21 CFR part 820).  Through this proposed rulemaking, FDA intends to converge its requirements with quality management system requirements used by other regulatory authorities,” as noted above.

The Agency is taking this action to harmonize with other international regulators by incorporating by reference ISO 13485 into part 820 as the Agency has determined that the ISO requirements are essentially consistent with current part 820.  “As such, FDA proposes to withdraw the requirements in the current part 820, except that we propose to retain the scope of the current regulation and to retain and modify, as indicated [in the proposed rule], a number of the definitions in the current part 820.”  The resultant new regulation will be referred to as the Quality Management System Regulation (QMSR).

It behooves all in the medical device industry to carefully review this proposed rule and make appropriate comments to Docket No. FDA‑2021‑N‑0507 if you have disagreements, suggestions for changes, or need clarification of sections of the proposed rule during the comment period and prior to FDA’s finalization of the rule.  Lachman Consultants would be happy to assist you in your understanding of the new provisions of the rule.  Please direct your initial contact to Michele Sinoway at