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Is the FDA Really Replacing the QS Reg??

By: Mark Swanson, QRx Partner

As we wind down in 2023, many people still hope that the final rule for the US Quality Management System Regulation will be coming soon (and still a few think it will never come). This will replace most of the current Quality System Regulation (QSReg) in 21CFR820 and some of the combination products regulation (21CFR4) with the requirements from ISO 13485.

It appears that CDRH has completed its work, as the latest update is that the final version has been accepted for review at the final step in the Federal Register under registration identification number (RIN) 0910-AH99. As of December 6, 2023, it is pending review as a final rule through the Office of Management and Budget or OMB. This process is generally no longer than 90 days. This means we can expect the final rule to be published sometime early in the first quarter of 2024.

It does seem that the FDA has begun the implementation activities (technology updates, training of FDA personnel, replacement of QSIT, and other documentation) they outlined. It is likely that shortly after the final rule is published, we can expect guidance documents and other information to be coming as well. If you don’t have a copy of the ISO standard, remember a critical aspect that is allowing the FDA to implement this use of ISO 13485 by reference is the American National Standards Institute (ANSI) incorporated by reference IBR portal. The standard is available as a read-only to allow free access to the standard.

As for the final rule text, this is just conjecture, but based on the comments received, there won’t be many differences from the draft rule. The comments received can be viewed here. For specific questions about the proposed rule, the FDA provides the email

If you have concerns about how this affects your company, QRx Partners is here to help!

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