Need to be really clear about the indication for use and the NEW benefit offered by the device. The breakthrough indication may be broader than your IND trial inclusion and exclusion criteria. Expect more than one RAPID teleconference call meetings to clarify details with FDA. Ask really good questions (I.e., not yes/no questions which have little value). Listen carefully!!!
In my experience (some this month), the FDA has been extremely helpful and clear in their guidance to breakthrough applicants. Applicants have not always been clear in their expectations or willingness to hear the guidance given. Get someone on your team who has done this before to help pull things together inside the company as well as the team at FDA does inside the FDA. Do not waste time.
Joy Frestedt, PhD, CPI, RAC, FRAPS, FACRP
JF@frestedt.com952-426-1747
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Original Message:
Sent: 4/21/2021 3:21:00 PM
From: Anonymous Member
Subject: Breakthrough Device Designation
This message was posted by a user wishing to remain anonymous
Hello,
I'd be interested in hearing about any experiences with the FDA Breakthrough Device Designation program. We are aligning to the FDA guidance in terms of content and structure of the request.
How was the initial Q-sub meeting? Any advice or perspective you can share would be appreciated.
Thank you!