On Feb. 23, 2022, the U.S. Food and Drug Administration (FDA) released its proposed rule for the new Quality Management System Regulation (QMSR). The proposed QMSR will be the result of aligning the current good manufacturing practice (cGMP) requirements of the FDA’s Quality System Regulation (QSR) with the international consensus standard for medical device quality management systems, ISO 13485:2016.

Cue the applause, because the medical device industry has been buzzing about harmonization between FDA’s QSR and ISO 13485 since 2018 and now it’s finally happening.

Well, almost. The document the FDA released is a proposed rule. Right now, the agency asserts that publication of the final rule in the Federal Register will happen Dec. 00, 2023. (Yes, you read that “00” correctly. The agency seems to be giving itself a bit of wiggle room on exactly when it will be published.)

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