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

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

Collection:
Health Policy and Services Research
Contributor(s):
Center for Biologics Evaluation and Research (U.S.), issuing body.
Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, October 2023
Language(s):
English
Format:
Text
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.)
Genre(s):
Guideline
Technical Report
Abstract:
This guidance describes a standards recognition program for regenerative medicine therapies (SRP-RMT) at FDA’s Center for Biologics Evaluation and Research (CBER) designed to identify and recognize Voluntary Consensus Standards (VCS) to facilitate the development and assessment of regenerative medicine therapy (RMT) products regulated by CBER when such standards are appropriate. CBER encourages the use of appropriate standards in the development of CBER-regulated products. The use of recognized VCS can assist stakeholders in more efficiently meeting regulatory requirements and increasing regulatory predictability for RMT products. This program is modeled after the formal standards and conformity assessment program or S-CAP for medical devices. 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 guidances 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 (i, 11 pages))
NLM Unique ID:
9918732188006676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918732188006676