Recognition and withdrawal of voluntary consensus standards: guidance for industry and Food and Drug Administration staff

Recognition and withdrawal of voluntary consensus standards: guidance for industry and Food and Drug Administration staff

Collection:
Health Policy and Services Research
Series Title(s):
Guidance for industry
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.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Publication:
Silver Spring, MD : Center for Devices and Radiological Health, September 15, 2020
Language(s):
English
Format:
Text
Subject(s):
Consensus
Equipment and Supplies -- standards
Voluntary Programs -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
The Food and Drug Administration (FDA) developed this document to provide guidance to industry and FDA staff about the procedures the Center for Devices and Radiological Health (CDRH) follows when we receive a request for recognition of a voluntary consensus standard for medical products. The guidance outlines principles for recognizing a standard wholly, partly, or not at all, as well as reasons and rationales for withdrawing a standard.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (10 pages)).
NLM Unique ID:
9918232103506676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918232103506676