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OMB Completes Review Of FDA’s Draft Harmonized Quality System Regulation

Executive Summary

The White House Office of Management and Budget’s concluded action was “consistent with change,” which means modifications were made to the draft rule during its review.

The White House Office of Management and Budget (OMB) on 8 February completed its regulatory review of the US Food and Drug Administration’s draft harmonized Quality System Regulation.

The OMB finished its review in a swift 35 days. The FDA had sent the draft rule to the office on 5 January after working on it for nearly four years. (Also see "At Long Last, FDA Sends Draft Harmonized Quality System Regulation To OMB For Review" - Medtech Insight, 7 Jan, 2022.)

The OMB’s concluded action was “consistent with change,” which means modifications were made to the draft reg during its review. However, the “consistent with change” code doesn’t differentiate between small editorial tweaks and modifications that drastically alter a rule, so it’s difficult to discern if the changes were minor or if the FDA has to go back to the drawing board, let alone how long it might be before the draft is available to the public.

The agency has been harmonizing its Quality System Regulation with international quality systems standard ISO 13485:2016 since early 2018. The QSR has been the bedrock rule for manufacturing safe and effective medical devices to be sold in the US since the mid-1990s, while ISO 13485 is used by device firms to ensure quality systems compliance with regulators in a variety of countries.

 

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