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?
Recent Updates
- The Battle Continues: No Appointments Clause Problem, BUT Eleventh Circuit Directs District Court to Consider Whether False Claims Act Qui Tam Provisions Violate Take Care, Vesting Clauses
- Bill Gates Gazes into the AI Crystal Ball: What are the Implications on the Healthcare and Life Sciences Industry
- 250+ Health Care Entities Targeted by HHS, DOJ Over Gender-Affirming Care for Minors
- Exclusion Authority (It’s Not Just the HHS-OIG Anymore …)
- The Sixth Circuit Revives the Medicare Waiver of Liability for Overpayments and Appeals