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# Guidance on Device Postmarket Surveillance
- URL: https://www.fdaweb.com/guidance-on-device-postmarket-surveillance/
- Published: 2016-05-17T12:00:00.000Z
- Updated: 2026-09-14T21:03:15.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135687

*Federal Register* Notice: FDA is making available a guidance entitled *Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act.* It is intended to assist manufacturers of devices subject to Section 522 postmarket surveillance orders by providing an overview of the Federal Food, Drug, and Cosmetic Act, information on how to fulfill section 522 obligations, and recommendations on the format, content, and review of postmarket surveillance plan submissions. To download this guidance, click [here](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM268141?ref=fdaweb.com). To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-05-16/pdf/2016-11450.pdf?ref=fdaweb.com).