QMSR Harmonization Curiously Missing from Spring 2023 Regulatory Agenda

A year ago, we blogged about a proposed rule that would replace the Quality System Regulation (QSR) at 21 C.F.R. Part 820 with a newly named Quality Management System Regulation (QMSR) (see here). The proposed rule was published on February 23, 2022 and was first heralded by FDA in 2018 and introduced in the Spring 2018 regulatory agenda. In the proposed rule, FDA stated that any final rule would become effective one year after the date of publication of the final rule in the Federal Register.

It is noteworthy that the one-year anniversary of the proposed rule has come and gone.

Keen observers may have noticed that in the most recent semiannual regulatory agenda, neither the Quality System Regulation nor the Quality Management System Regulation is referenced. This suggests that it is unlikely we will see harmonization of the QSR with ISO 13485 in 2023.

From a historical perspective, FDA issued a final rule in the Federal Register of July 21, 1978, outlining the current good manufacturing practice (CGMP) requirements for medical devices. The regulation became effective on December 18, 1978 and was codified under part 820. In the intervening years between 1978 and 1996, editorial changes were made to update organizational references and revise the list of critical devices included in the preamble.

The Safe Medical Devices Act of 1990 provided FDA with the authority to include design controls in the regulation. FDA also took steps to ensure, to the extent possible, that the CGMP regulation would be consistent with the quality system requirements in applicable international standards. FDA published a proposed rule with revisions to part 820 on November 23, 1993. Nearly three years later, the rule was finalized on October 7, 1996 with the regulation becoming effective June 1, 1997.

This is all to say we recognize the tremendous efforts underway to harmonize the QSR with ISO 13485. We hope to see the topic back on the agenda in the fall and will post an update when the rule is eventually finalized or if anything noteworthy happens before then.