Hello Akanksha,
The simplest answer would be to contact your TPR to inquire with them on how the communication should be handled as this should be done consistent with the TPR programme. Therefore, according to the guidance document
https://www.fda.gov/media/85284/download the response should be sent back through the TPR. They review, FDA reviews, FDA communicates to TPR, TPR communicates to you. It sounds like even FDA is not following their own process because even if there is an AI it should be communicated through the TPR. Personally, if you have already had interaction with FDA, I would cut the TPR out and deal with the FDA directly to ensure best success of getting clearance. I am not a proponent of the TPR programme, because why deal with a middle man when you can deal with the source directly? I know there are supposed benefits with quicker review times. However, this is the exact problem with the TPR is they conduct the review, then FDA still completes a partial/full review with additional information being asked. I know FDA is supposed to be reducing the number of re-reviews, but until the TPR is truly a third party review then I do not see the benefit (off the soap box).
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 15-Dec-2020 10:53
From: Akanksha Asbe
Subject: Third Party Reviewer communication with FDA
Hello Everyone, We currently have a 510(k) on hold. We are using a third-party reviewer. The TPR submitted a SE determination to FDA, FDA had 2 AI questions that put the submission on hold. We had an AI meeting to discuss and clarify the AI requests, and this was the first interaction with FDA that the sponsor (we) had. All other interactive review questions went through the TPR. Within our organization we have differing views. Some leadership would like to send meeting minutes to FDA, copying the TPR to confirm the actions agreed to during the AI meeting. This same group of leadership would like the sponsor to interact directly to the FDA and copy the TPR on communications to ensure alignment. There are other members of leadership that feel that since we are using a TPR, all communications need to be generated by the TPR, and we/the sponsor should not be generating minutes and initiating communications with FDA. The TPR should still be facilitating all FDA communications and that minutes are not necessary or expected by FDA following an AI meeting.
We would appreciate your perspective on this, and any direct experiences with submissions on hold when using a TPR.
Thank you,
Akanksha Asbe
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Akanksha Asbe
Regulatory Affairs Specialist II
Clinton MA
United States
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