Guide on Devices Used with Regenerative Medicine Therapies

Federal Register notice: FDA has made available a final guidance entitled “Evaluation of Devices Used with Regenerative Medicine Advanced Therapies (RMAT)” that provides the agency’s current thinking about how it intends to simplify and streamline its application of regulatory requirements for combination device and cell or tissue products. It discusses the intended uses or specific attributes that would result in a device used with a regenerative therapy product being placed in Class 3, and the factors to consider in determining whether a device may be labeled for use with a specific RMAT or class of RMATs. The document also addresses when a device may be limited to a specific intended use with only one particular type of cell, and application of the least burdensome approach to demonstrate how a device may be used with more than one cell type. To view the notice, click here.