Appropriate use of voluntary consensus standards in premarket submissions for medical devices: guidance for industry and Food and Drug Administration staff Appropriate use of voluntary consensus standards in premarket submissions for medical devices: 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 Biologics Evaluation and Research (U.S.), issuing body. Center for Drug Evaluation and Research (U.S.), issuing body. Publication: Silver Spring, MD : Center for Drug Evaluation and Research, September 14, 2018 Language(s): English Format: Text Subject(s): Clinical Trials as Topic Consensus Device Approval Equipment and Supplies -- standards United States United States. Department of Health and Human Services United States. Food and Drug Administration United States. Genre(s): Guideline Technical Report Copyright: The National Library of Medicine believes this item to be in the public domain. (More information) Extent: 1 online resource (1 PDF file (iii, 13 pages)). NLM Unique ID: 101734447 (See catalog record) Permanent Link: http://resource.nlm.nih.gov/101734447