Unpacking Averages: Assessing Whether FDA’s Breakthrough Device Designation Is Helpful
Health Law Advisor
AUGUST 2, 2022
My goal in nearly every device submission is to try to get through the FDA process with as little attention from FDA as possible. But when a seasoned person looks at it who has experience with FDA, their first thought is, do I really want FDA more involved in the process? Free advice! That’s not a criticism.
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