Unpacking Averages: Assessing FDA’s Focus on Enforcing 510(K) Requirements on Imports
Health Law Advisor
SEPTEMBER 6, 2022
A private equity client asked us recently to assess a rumor that FDA was on the warpath in enforcing the 510(k) requirement on medical devices from a particular region. Over the last 22 years reflected in the database, there have been approximately 125,000 refusals of device shipments. Turns out, the agency was not. Methodology.
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