Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi all. Have any of you had, or know of, an FDA inspection prior to FDA's determination decision on a De Novo submission?

Per 21 CFR 860.240(c), FDA "may" inspect, and per the FR notice announcing the final rule in Oct. 2021, the agency said such inspections would be infrequent -- reserved for situations where data integrity is suspect or the manufacturing process has elements raising concerns that additional controls might be needed -- but how common are such inspections in practice? (If you're able to provide context, all the better)

Thanks!

Hello Anon,

Indeed the regulation allows FDA to conduct "pre-inspections" of De Novo similar to what is mandatory for Premarket Applications (PMA), does include the "may" in the regulation.  Personally, I have not experienced nor head of a pre-inspection as part of a De Novo submission.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 24-Feb-2023 11:15
From: Anonymous Member
Subject: Inspections for De Novo submissions: Experience?

This message was posted by a user wishing to remain anonymous

Hi all. Have any of you had, or know of, an FDA inspection prior to FDA's determination decision on a De Novo submission?

Per 21 CFR 860.240(c), FDA "may" inspect, and per the FR notice announcing the final rule in Oct. 2021, the agency said such inspections would be infrequent -- reserved for situations where data integrity is suspect or the manufacturing process has elements raising concerns that additional controls might be needed -- but how common are such inspections in practice? (If you're able to provide context, all the better)

Thanks!