FDA Issues Guidance on Postmarket Device Studies

The FDA has outlined its expectations for postmarket surveillance of moderate and high-risk devices in two draft guidances.

The agency may order postmarket surveillance for devices covered under Section 522 of the Food, Drug and Cosmetic Act, which authorizes the FDA to require such surveillance at any time in the lifecycle of certain Class II (moderate risk) and Class III (high risk) devices.

Once a Section 522 order is received from the agency, devicemakers should submit a surveillance plan within 30 days and the surveillance should be conducted no later than 15 months after the day the order is issued, the agency says.