REGULATORY UPDATE: FDA Revises Collection of Information Request Related to Standards Recognition Program for Regenerative Medicine Therapies

August 15, 2023

The Food and Drug Administration issued a revised collection of information request in Tuesday’s Federal Register to support implementation of a standards recognition program for regenerative medicine therapies (SRP-RMT) at FDA’s Center for Biologics Evaluation and Research (CBER). 

The agency designed the (SRP-RMT) 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. The June 2022 draft guidance for industry, “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies,” describes procedures CBER will follow when a request for recognition of a VCS is received.

After the initial 60-day comment period, FDA received feedback, including comments from AABB, advocating for a broad application of a voluntary consensus program. No comments were received addressing the provisions related to the recognition information collection, the necessity of the information for FDA, the accuracy of the agency's burden estimate, ways to enhance the quality and clarity of the information collected, and methods to minimize the burden of the information requests.

FDA is actively considering the comments from product sponsors, applicants and other stakeholders invested in the development of CBER-regulated RMT products as the guidance is being finalized. The deadline to submit comments is Sept 14.