FDA to increase transparency, reporting and timely completion for medical device studies after FDA approval

May 28, 2021

The U.S. Food and Drug Administration (FDA) issued two guidances regarding the surveillance of certain medical devices.

The first guidance on postmarket surveillance guidance will assist manufacturers of devices subject to an order under section 522 of the Federal Food, Drug, and Cosmetic Act, which authorizes the FDA to require postmarket surveillance (522 order) at any time in the lifecycle of certain Class II (moderate risk) and III (high risk) devices that meet any of the following criteria: a failure with the device would be reasonably likely to have a serious adverse health consequence; the device is expected to be used significantly in pediatric populations; the device is intended to be implanted in the human body for more than one year or a device that is intended to be life-sustaining; or life-supporting and used outside of a device user facility.

The postmarket surveillance guidance includes information to assist manufacturers with completing their postmarket surveillance plan according to the 522 order in a timely manner and FDA’s policy of posting information about postmarket surveillance in the 522 Postmarket Surveillance Program Database.

The second guidance is an updated post-approval study guidance that will assist stakeholders with understanding post-approval study requirements imposed as a condition of PMA approval by providing procedural information, recommendations concerning post-approval related submissions and other.

Post-approval studies may be required as a condition of approval for a premarket approval application and are typically intended to gather specific data to address questions about the postmarket performance of or experience with an approved medical device. As described in Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval Guidance, the FDA may also consider applying such postmarket controls as a way to reduce premarket data collection, when appropriate, to improve patient access to safe and effective medical devices that are important for public health.

FDA has the release.