Hello Anon,
At the request for Additional Information (AI) stage for a Special 510(k) the timeline is the same for a Traditional submission as well - 180 days to respond. The clock FDA has for Special 510(k) submission does not "reset" this is a target timeframe for them to review these type of submissions. Their "target" timeframe for review of a Special 510(k) is 30 days which is fairly close to the time they review them in - but remember this is their time, not your time if there is an AI request made.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 28-Dec-2022 18:15
From: Anonymous Member
Subject: Special 510(k) review clock
This message was posted by a user wishing to remain anonymous
Hi All- If you receive an additional information request on a Special 510(k), my recollection is that FDA restarts the clock with 30 or 60 days rather than the number of days remaining on the original 30-day clock. I cannot find this scenario in the guidance. Can someone remind me? Thanks!