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. Such a government initiative would significantly deter investments in the companies doing the importing. Turns out, the agency was not. The FDA’s recent activities in the region were well within their historical norms.
But the project got us thinking, what does the agency’s enormous database on import actions tell us about the agency’s enforcement priorities more generally? There are literally thousands of ways to slice and dice the import data set for insights, but we picked just one as an example. We wanted to assess, globally, over the last 20 years, in which therapeutic areas has FDA been enforcing the 510(k) requirement most often?
Blog Editors
Recent Updates
- Watch: FDA’s 2026 Enforcement Priorities: What In-House Counsel Must Know – Thought Leaders in Health Law
- The Future of 340B: New Bills Offer Competing Solutions to Modernize the 340B Drug Discount Program
- "Enough Is Enough": HHS-OIG Freezes Funds for New York Medicaid Fraud Control Unit, Effective July 1
- Straight From the Source: AHLA Annual Meeting Highlights Fraud and Abuse Enforcement Efforts in 2026 and Beyond
- At the Half: No Free Kicks in FDA’s 2026 Enforcement