Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi,

If a sponsor needs to report an adverse event under an IDE what is the best way to do that? Is there a FDA form to do that?

Thanks!

Refer to section IV in the below guidance:

https://www.fda.gov/media/72267/download

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Loganathan Kumarasamy, MS RAC
Senior Consultant
Waukegan IL
United States
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Original Message:
Sent: 18-Aug-2019 17:31
From: Anonymous Member
Subject: Adverse event reporting under IDE

This message was posted by a user wishing to remain anonymous

Hi,

If a sponsor needs to report an adverse event under an IDE what is the best way to do that? Is there a FDA form to do that?

Thanks!