Health Law Advisor

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.