FDA Q-Submission Informational Meeting

tebusse

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#1
Greetings everyone,

Has anyone submitted to the FDA a Pre-Submission Informational Meeting Request? The guidance document for the Pre-Sub Program does make it relatively clear regarding what to include in the request, however, I'm wondering what, if any, background information regarding the device should be included.

Additionally, if anyone has had experience with an informational meeting, I'd be interested in learning about it. Particularly, was the meeting helpful for your company.

Best regards, Tonia
 
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