While all good points, the date on the publicly available database of 510(k) clearance is based upon the final 510(k) Summary document that was updated due to the additional work required to end the review and not the date the submission was accepted by the FDA initially. As a result, the date on the 510(k) Summary provided on the 510(k) database gives a date that is substantially more recent than the date the submission was sent to the FDA. For example, if I submit the package on 1 January 2022 but then with all the back-and-forth to provide information to address all the questions, both interactive and AINN, all the issues are not resolved until 1 December 2022, and the information provided to address those questions causes an update to the 510(k) Summary, then you will have the updated 510(k) Summary with a date of 1 December 2022, which is what the public sees. So, if the clearance letter is issued with a date of 15 December, that does not mean that the review took only 14 days. While the dates on the database are helpful, they do not precisely reflect the time from submission to clearance.
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Thomas Lawson PhD
Principal Consultant
El Cerrito CA
United States
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Original Message:
Sent: 26-Jan-2023 04:43
From: Anonymous Member
Subject: Average 510k clearance time by product code
This message was posted by a user wishing to remain anonymous
Hi,
I am looking for a publicly available source that allows average clearance time for 510k for a given product code. Does a system like this exist?
Regards.