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