March 4, 2019 — The U.S. Food and Drug Administration (FDA) recently finalized two guidance documents regarding regenerative medicine therapies. In the cardiology arena, there are ongoing research efforts and several clinical trials looking at the use of stem cells to repair myocardial infarcts following heart attacks. If cardiac tissue regeneration became viable, it holds the promise of greatly reducing heart failure, which is a major cost driver in the U.S. healthcare system.
Both documents were first issued in draft in November 2017 as part of a suite of guidances that comprised the FDA’s comprehensive regenerative medicine policy framework.
The first final guidance, Evaluation of Devices Used with Regenerative Medicine Advanced Therapies, which is required by the 21st Century Cures Act, clarifies how the FDA will evaluate devices used in the recovery, isolation or delivery of regenerative medicine advanced therapies (RMATs). The guidance specifies that devices intended for use with a specific RMAT may, together with the RMAT, be considered to comprise a combination product.
Read the first final guidance here.
The second final guidance, Expedited Programs for Regenerative Medicine Therapies for Serious Conditions, describes the expedited programs that may be available to sponsors of regenerative medicine therapies for serious conditions, including the new Regenerative Medicine Advanced Therapy (RMAT) designation created by the 21st Century Cures Act, Priority Review designation and Accelerated Approval. In addition, the guidance describes the regenerative medicine therapies that may be eligible for RMAT designation.
Read the second final guidance here.
For more information: www.fda.gov
March 25, 2025 
