This guidance provides manufacturers, applicants, and sponsors engaged in the development of regenerative medicine therapies, with FDA’s current thinking regarding evaluation of devices used in the recovery, isolation, or delivery of regenerative medicine advanced therapies.
Section 3034 of the 21st Century Cures Act (Cures Act) mandates that FDA issue guidance clarifying how FDA will evaluate devices used in the recovery, isolation, or delivery of regenerative advanced therapies, as such term is used in section 506(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 356(g)) and which FDA generally refers to as “regenerative medicine advanced therapies” or “RMATs.” Accordingly, this guidance discusses what FDA will consider when evaluating the devices used with RMATs. This document includes information about the Agency’s current thinking regarding a wide range of concepts related to the regulation of devices, as they apply to devices used in the recovery, isolation, and delivery of RMATs. Specifically, this guidance addresses how FDA intends to simplify and streamline its application of regulatory requirements for combination device and cell or tissue products; what, if any, intended uses or specific attributes would result in a device used with a regenerative therapy product to be classified as a Class III device; the factors to consider in determining whether a device may be labeled for use with a specific RMAT or class of RMATs; 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.