Most months, I try to answer a well-focused question. This month, however, I want to simply take a broad look at how FDA conducts its postmarket surveillance study program under Section 522 of the federal Food, Drug, and Cosmetic Act. FDA published a new final guidance on this topic on October 7, 2022, and the agency also made corresponding updates to its database. That gave me the chance to study the data, however incomplete they are. More on that later.
Overview of the Guidance and the Program
Before I turn to the data, I thought it would be helpful to provide a high-level reminder of what FDA’s postmarket surveillance study program is all about. As explained in the guidance, Section 522 provides FDA with the authority to require manufacturers to conduct postmarket surveillance at the time of approval or clearance or at any time thereafter of certain class II or class III devices. I’ll talk more about the question of timing below.
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