Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies

June 16, 2022

Computer generated rendering molecules, cells, and DNA structures.

Guidance Document

Draft Guidance for Industry

June 2022

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.

Download the Draft Guidance Document

Draft

Not for implementation.

Contains non-binding recommendations.

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TAGS: FDA North America VCS Agency Alerts SRP-RMT CBER Regulatory Sciences

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