QMSR: FDA previews questions ahead of device GMP adcomm

After proposing to align its medical device Quality System Regulation (QSR) with the international standard ISO 13485:2016, the US Food and Drug Administration (FDA) has offered a look at its chief questions for experts and industry ahead of a key meeting to review the proposed rule.

After years of anticipation, FDA last week released its proposed rule to align the QSR – the current good manufacturing practice (cGMP) requirements for medical devices in the US – with ISO 13485. The resulting regulation would be called the Quality Management System Regulation (QMSR). (RELATED: QMSR: FDA proposes QSR overhaul after years of delays, Regulatory Focus 22 February 2022)

“For over two decades, the medical device cGMP requirements for the United States have been the QS regulation; and fundamentally unchanged. This proposed change will require both the agency, and industry to prepare for a transition to meet the newly proposed requirements,” FDA wrote in an executive summary ahead of the meeting.

Shortly before releasing the proposed rule, FDA announced it would convene its Device Good Manufacturing Practice Advisory Committee for a public meeting on Wednesday for the first time since 2013 to review the proposed regulatory overhaul. Over the last two years, FDA has sought to fill vacancies on the committee and currently notes that the committee is fully staffed.

During the full-day meeting, FDA, industry groups, and others will give presentations on the proposed rule. FDA also plans to pose seven questions to the Devices Good Manufacturing Practice (DGMP) panel.

Those questions cover a range of topics related to FDA’s planned alignment with ISO 13485; the impact of the transition on industry, patients, and other stakeholders; and whether the agency has adequately identified the aspects of ISO 13485 that will require additional FDA-specific adjustments.

FDA also said it will ask whether it should provide education for manufacturers about the changes that would be brought on by the rule and how it can best support industry in preparation for the new requirements.

One of the biggest shifts that would be brought on by the alignment has to do with ISO 13485’s greater emphasis on risk management. FDA will ask panel members to provide their thoughts “on the equivalence of the more explicitly integrated risk management expectations in the proposed rule to the current regulation.”

Lastly, FDA will ask the panel for input on the development of a new inspection model that would be necessitated by the new rule. Specifically, FDA will ask about the regulatory considerations it should weigh when designing the new model, as well as what the panel thought worked well or didn’t work well in the current quality system inspection technique (QSIT) model.

Meeting materials

QMSR: FDA previews questions ahead of device GMP adcomm

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