Hello Anon,
The US FDA used to allow multiple rounds of Additional Information (AI) requests, but then 510(k) submissions would drag out a long time, companies would not address the requests properly, and it meant the "numbers" for FDA's metric reporting to be long. They came out in public a few years back (not in regulation) as Kevin says, one formal AI request, so that companies would do better job at addressing the deficiency rather than throwing information at the AI request hoping something sticks. I know during the pandemic they were a little less strict with this, but only one formal request is made. Then as Kevin says, usually after the formal AI request has been done, there can be one to many "interactive reviews" where they a immediate items to resolve, such as clarifying a report, updating an Instructions for Use (IFU), updating a 510(k) Summary, or "small" questions on the AI response; these are usually done through email or even a phone call.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 28-Oct-2022 11:09
From: Kevin Randall
Subject: Multiple AI requests during 510k Submission
We are generally only allowed one formal FDA AI request [i.e, a request that warrants the submission (and its FDA review clock) to be placed on "hold"].
I presume you aren't asking about FDA requests that can be resolved via "Interactive Review". Those are ones viewed by the agency to be less substantive, and less formal, and that thus don't warrant stoppage of the FDA review clock. My experience has been that the number of Interactive Review rounds is generally left to the discretion of the Lead Reviewer.
Here's the FDA guidance that addresses these topics.
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 27-Oct-2022 15:51
From: Anonymous Member
Subject: Multiple AI requests during 510k Submission
This message was posted by a user wishing to remain anonymous
Hello Open Forum!
I am wondering if someone could point to a guidance or FDA webpage that explicitly discusses multiple rounds of AI requests to a 510k. A question I would like to be able to answer is, If I send in an official response to an AI request, does FDA have the option to give a second AI request?
Thank you.