Dear Anon,
I assume that this clinical study is for an integrated or co-packaged device and is performed under a single IND. As such, all adverse event reports should be made to the division under which the application is submitted.
In addition, it is important that your protocol address, and report forms capture, any Device related adverse events and that these be reported under the IND. Finally, any failures of the device should be captured, recorded, and evaluated and provided as part of the clinical report.
Lee
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Lee Leichter RAC
President
Fort Denaud FL
United States
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Original Message:
Sent: 04-Oct-2022 12:35
From: Anonymous Member
Subject: combination safety reporting under IND
This message was posted by a user wishing to remain anonymous
We are prepping for a combination product trial being run under an open IND (in drug division). I have previously researched and thought I found information saying that safety reporting for premarket combination products should adhere to the division under which the application is submitted. But I cannot seem to find anything on this recently. I know there is a new postmarket combination reporting guidance, but can anyone direct me towards anything from FDA on premarket combination reporting?