Unpacking Averages: Assessing Whether FDA’s Breakthrough Device Designation Is Helpful
Health Law Advisor
AUGUST 2, 2022
You might be thinking, that’s an odd title: obviously FDA’s breakthrough device designation is helpful. However, after looking at the data, my conclusion is that I would avoid the breakthrough device designation for any product that qualifies for the 510(k) process. The process is likely not helpful for such devices. Background.
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