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.
Blog Editors
Recent Updates
- New York’s Health Information Privacy Act Poised to Become the Latest in a Growing Trend of State Data Privacy Laws
- Effective Dates of DEA Final Rules for Telemedicine Prescribing Delayed
- Video: 2025 Outlook - the Department of Health and Human Services Under the Second Trump Administration – Diagnosing Health Care
- The NIH IDC – Where Are We Now
- False Claims Act Exposure in Focus: President Trump Signs Executive Order Targeting DEI Programs