On Mar. 25, 2024, PDA announced at its 2024 Annual Meeting in Long Beach, Calif., "ANSI/PDA 02-2021 Cryopreservation of Cells for Use in Cell Therapies, Gene Therapies, and Regenerative Medicine Manufacturing" has been included in a listing of recognized standards for regenerative medicine therapies by the U.S. FDA Center for Biologics Evaluation and Research. FDA released the list following the publication of "Guidance for Industry: Voluntary Consensus Standards Recognitions Program for Regenerative Medicine Therapies" in October 2023.
ANSI/PDA 02-2021 received the status of "Complete Recognition," a designation meaning the entire content of the standard is recognized. This is the first standard published by ANSI/PDA recognized by FDA since PDA became an ANSI-accredited standards developer in 2017.
