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GUIDANCE DOCUMENT

Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act Guidance for Industry and Food and Drug Administration Staff October 2022

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2011-D-0514
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

Section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) provides the Food and Drug Administration (FDA) with the authority to require manufacturers to conduct postmarket surveillance at the time of approval or clearance or at any time thereafter of certain class II or class III devices. Postmarket surveillance is the active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device.  The data collected under a surveillance order help to address important public health questions on the safety and effectiveness of a device. The purpose of this guidance document is to assist manufacturers of devices subject to section 522 postmarket surveillance orders (522 orders) by providing information on how to fulfill section 522 obligations. The final guidance “Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act” is intended to update and replace the guidance issued in May 2016.

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All written comments should be identified with this document's docket number: FDA-2011-D-0514.

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