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. The FDA’s recent activities in the region were well within their historical norms. To be sure, FDA can have multiple reasons for refusing entry. Background.
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