- The U.S. Office of Information and Regulatory Affairs (OIRA) has completed a review of an FDA proposed rule about harmonizing and modernizing the regulation of medical device quality systems.
- OIRA, which is part of the White House's Office of Management and Budget, found the FDA proposal to be consistent with the principles set out in an executive order on regulatory planning and review, but the text has undergone changes since FDA sent it to the office last month.
- The conclusion positions FDA to publish a long-awaited proposed rule that is intended to reduce compliance and recordkeeping burdens on device manufacturers by bringing U.S. quality system requirements in line with standards that have been internationally adopted, called ISO 13485:2016, which the FDA began transitioning to in 2018.
FDA set out its plans to harmonize with international standards in 2018. At that time, FDA pitched the change as a way to enable more robust and globally harmonized quality management systems. FDA expected to publish a proposed rule in the fall of 2019, although it warned the changes would have a significant impact on its activities and require a multi-year transition.
In the end, FDA submitted the proposed rule to OMB in January 2022, more than two years after it was supposed to be released for consultation. OIRA, which has 90 days to review proposed rules, took 35 days to complete its assessment of the FDA document.
OIRA's goal is to ensure "the President's policies are reflected in agency rules" and compliance with the principles set out in a Clinton-era executive order. FDA's proposed rule met those requirements, clearing the agency to release it for public consultation, but has undergone changes since being submitted.
The extent of the revisions is unclear. OIRA labeled its action as "Consistent with Change," one of a small number of possible outcomes. According to the Center for Effective Government, the term means "OIRA generally agreed with the intent of the rule, but made some substantive changes."
A report by the U.S. Government Accountability Office, albeit from almost 20 years ago, said the term "does not indicate whether the changes made to agencies' rules during the formal review process had been suggested by OIRA or the agencies, or whether the changes were substantive or editorial in nature."
Whatever the extent of the changes, the OIRA conclusion marks another step forward for plans to bring U.S. quality system rules in line with international standards. If FDA follows up by releasing the proposed rule, the wider world will finally get a look at, and chance to comment on, its thinking.