Subjects: Voluntary Programs / Genre: Guideline - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Voluntary Programs ✖ Genre Guideline ✖

1. Appropriate use of voluntary consensus standards in premarket submissions for medical devices: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 14, 2018
Subject(s):: Clinical Trials as Topic
Consensus
Device Approval
Equipment and Supplies -- standards
Voluntary Programs
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

2. Fostering medical device improvement: FDA activities and engagement with the voluntary improvement program : guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, September 15, 2023
Subject(s):: Government Regulation
Medical Device Legislation
Quality Improvement
Voluntary Programs
United States

3. Voluntary consensus standards recognition program for regenerative medicine therapies: guidance for industry

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, October 2023
Subject(s):: Drug Industry
Government Regulation
Reference Standards
Regenerative Medicine -- legislation & jurisprudence
Regenerative Medicine -- standards
Voluntary Programs
United States
Center for Biologics Evaluation and Research (U.S.)