Search SciPol

Brought to you by
February 15, 2018 5:00 pm

Comment Deadline: FDA Evaluation of Devices Used With Regenerative Medicine Advanced Therapies

  • Government
  • Agency
  • Statute
  • Genetics/Genomics

The Food and Drug Administration (FDA) is announcing the availability of and soliciting public comments on a draft document entitled “Evaluation of Devices Used with Regenerative Medicine Advanced Therapies; Draft Guidance for Industry.” The draft guidance document, when finalized, will provide device manufacturers, applicants, and sponsors engaged in the development of regenerative medicine therapies, with our current thinking regarding evaluation of devices used in the recovery, isolation or delivery of regenerative advanced therapies, which FDA generally refers to as “regenerative medicine advanced therapies” or “RMATs.” Specifically, as required by the 21st Century Cures Act (Cures Act), the draft guidance addresses how FDA intends to simplify and streamline its application of regulatory requirements for combination device and cell or tissue products; what, if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; 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.

Members of the public may submit comments at Regulations.gov or via the Postal Service. More information is available via the Federal Register notice.