I would be interested to know if FDA has ever let someone slide on one of its deadlines to correct deficiencies in a submission. I was taught that they were set in stone, and, whenever the subject came up among colleagues, everyone else seemed to have been taught the same...miss the deadline, submission withdrawn, period, so I've never known of a situation in which someone missed one.
If I go with the common wisdom, I would give up on the notion that the meeting was for the purpose of appealing the deletion, and I would treat it as a pre-sub. I'd take advantage of the opportunity to confirm that what I had been planning to submit as a response will be sufficient to address all of the remaining deficiencies when I include it in the new 510(k).
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com------------------------------
Original Message:
Sent: 14-Feb-2020 14:18
From: John Samorajczyk
Subject: appeal of a 510(k) deletion
Has anyone ever had a meeting with the FDA following an appeal of a deletion of a 510(k). In this case the requested additional information was
late two days. The submitter appealed the deletion and the FDA scheduled a meeting.
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John Samorajczyk
Samorajczyk Regulatory Consultants, LLC
St Pete Beach FL
United States
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