REGULATORY UPDATE: New FDA Guidance Describes Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies

The Food and Drug Administration released a final guidance on Oct. 19 that describes a standards recognition program for regenerative medicine therapies (SRP-RMT) at FDA’s Center for Biologics Evaluation and Research (CBER) to recognize and use voluntary consensus standards (VCS) for the development and evaluation of regenerative medicine therapy (RMT) products. The guidance also describes how CBER intends to review for recognition in the SRP-RMT. 

Through the program, CBER aims to promote the adoption of appropriate standards to streamline regulatory compliance and increase predictability for RMT products, following a model similar to the one used for medical devices.  

Those interested in submitting online or written comments on the guidance may do so at any time. Instructions are available online.