FDA Issues Guidance on Certain Postmarket Studies

The FDA May 16 issued a guidance to help medical device makers conduct certain agency mandated postmarket surveillance studies.

The guidance, titled Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act (FDCA), was in a May 16 Federal Register notice (81 Fed. Reg. 30,311).

Postmarket surveillance under Section 522 of the FDCA is one means by which the the Food and Drug Administration can obtain additional safety and/or effectiveness data for a device when it’s necessary to protect the public health after it has been cleared through the 510(k) premarket process or approved through the premarket ...