> ## Content Index
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# Device Postmarket Surveillance Draft Guide
- URL: https://www.fdaweb.com/device-postmarket-surveillance-draft-guide/
- Published: 2021-05-27T12:00:00.000Z
- Updated: 2026-09-14T17:00:54.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5149416

*Federal Register* notice: FDA has made available a draft guidance entitled *Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act.* The document is intended to update a 2016 guidance to increase transparency to stakeholders on FA’s approach to the issuance and tracking of postmarket surveillance orders, and expectations for timely study completion. To view the notice, click [here.](https://www.govinfo.gov/content/pkg/FR-2021-05-27/pdf/2021-11215.pdf?ref=fdaweb.com)