2 Final Guidances on Regenerative Medicine

FDA has finalized two guidance documents on regenerative medicine therapies that were issued as drafts 11/2017 as part of the agency’s comprehensive regenerative medicine policy framework. The first guidance, Evaluation of Devices Used with Regenerative Medicine Advanced Therapies, is intended to clarify how the agency will evaluate devices used in the recovery, isolation or delivery of regenerative medicine advanced therapies (RMATs). It specifies that devices intended for use with a specific RMAT may, together with the RMAT, be considered to comprise a combination product.

The second 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 (RMAT) designation created by the 21st Century Cures Act. In addition, the document describes the regenerative medicine therapies that may be eligible for RMAT designation.