Regenerative Medicine Products

As of May 2021, the FDA intends on regulating the Regenerative Medicine products under the applicable classification of biological products, devices and/or drugs that are subject to premarket approval requirements. The FDA provided a period of enforcement discretion and a sufficient window of notification concerning the Investigational New Drug (IND) and Premarket Approval (PMA) requirements to ensure all manufacturers have adequate time to assess necessary steps for preparation and submission of any required applications to the FDA. This enforcement is for certain human cell, tissue and cellular and tissue-based products (HCT/Ps), including regenerative medicine therapies. The Clinical Services Team has created this document to answer the clinical question, “What do the new FDA regulations on Regenerative Medicine products mean for those using these products?”