Medical Device Makers Get Tips on Safety Monitoring After Sales

The FDA plans to issue postmarket surveillance orders to certain manufacturers of pacemakers and other devices to better understand adverse events or verify products’ long-term safety, according to final guidance published Thursday.

The Food and Drug Administration finalized a pair of guidance documents to assist makers of intermediate-to-high risk devices on how to comply with product monitoring requirements after a device is on the market. The agency’s nonbinding recommendations build on those included in draft guidance documents from May 2021.

The first document includes recommendations for makers of devices subject to Section 522 of the Federal Food, Drug, and Cosmetic ...