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GUIDANCE DOCUMENT

Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act Draft Guidance for Industry and Food and Drug Administration Staff May 2021

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

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


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.

This draft guidance document, when finalized, will assist manufacturers of devices subject to section 522 postmarket surveillance orders (522 orders) by providing:

  • an overview of section 522 of the FD&C Act;
  • information on how to fulfill section 522 obligations, including:
    • when postmarket surveillance should be considered commenced;
    • recommendations for achieving an approved postmarket surveillance plan in a timely manner; and
    • recommendations for enrollment schedules to help achieve timely completion of postmarket surveillance;
  • recommendations on the format, content, and review of postmarket surveillance plan and report submissions, including revised FDA review times for postmarket surveillance-related submissions; and
  • updated surveillance status categories to better reflect progress.

This draft guidance document also aims to increase transparency to stakeholders on FDA's approach to the issuance and tracking of 522 postmarket surveillance orders, and expectations for timely study completion. Our initiative to increase transparency includes posting the manufacturers' progress on addressing section 522 orders on FDA's website.

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