Sophia,
In the last couple years, we did see some longer review periods - as noted above especially in the IVD review teams. While IVD review times are still quite longer, we are seeing other branches (except maybe surgical products) getting a bit back to normal.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 15-Feb-2023 11:04
From: Anonymous Member
Subject: 180-day traditional PMA FDA review timeline
This message was posted by a user wishing to remain anonymous
We filed our 510(k) last year around this time and it was drastically impacted by COVID. Of course, we were filing into the IVD group, so that may have had something to do with it. FDA did communicate early after our submission that the review time would be substantially different than normal (projected to be more than twice the normally expected 90-day review time). Hopefully, that is going back to normal now.
Original Message:
Sent: 14-Feb-2023 13:42
From: Sophia Zhang
Subject: 180-day traditional PMA FDA review timeline
Does anyone know if FDA is sticking to their promised review timelines, especially for the 180-day traditional PMA submission, and 90-day Modular PMA submission? Do we still expect any delay because of Covid?
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Sophia Zhang
Stoughton WI
United States
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