Postmarket surveillance under section 522 of the Federal Food, Drug, and Cosmetic Act: guidance for industry and Food and Drug Administration staff

Postmarket surveillance under section 522 of the Federal Food, Drug, and Cosmetic Act: guidance for industry and Food and Drug Administration staff

Collection:
Health Policy and Services Research
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Devices and Radiological Health (U.S.), issuing body.
Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, October 7, 2022
Language(s):
English
Format:
Text
Subject(s):
Device Approval -- legislation & jurisprudence
Government Regulation
Product Surveillance, Postmarketing
United States
United States. Food and Drug Administration
Genre(s):
Guideline
Technical Report
Abstract:
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 guidance document will assist manufacturers of devices subject to section 522 postmarket surveillance orders (522 orders) by providing: (1) an overview of section 522 of the FD&C Act; (2) information on how to fulfill section 522 obligations, including: (a) when postmarket surveillance should be considered commenced; (b) recommendations for achieving an approved postmarket surveillance plan in a timely manner; and (c) recommendations for enrollment schedules to help achieve timely completion of postmarket surveillance; (3) 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 (4) updated surveillance status categories to better reflect progress. This guidance document also aims to increase transparency to stakeholders on FDA’s approach to the issuance and tracking of 522 orders, and expectations for timely study completion. Our initiative to increase transparency includes posting the manufacturers’ progress on addressing 522 orders on FDA’s website.3 In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (30 pages))
NLM Unique ID:
9918504288706676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918504288706676