Guidance Regarding Devices Used in the Recovery, Isolation, or Delivery of Regenerative Advanced Therapies
[Pub. L. 114–255, div. A, title III, § 3034], Dec. 13, 2016, [130 Stat. 1103], provided that:“(a)
Draft Guidance.—
Not later than 1 year after the date of enactment of the 21st Century Cures Act [Dec. 13, 2016], the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue draft guidance clarifying how, in the context of regenerative advanced therapies, the Secretary will evaluate devices used in the recovery, isolation, or delivery of regenerative advanced therapies. In doing so, the Secretary shall specifically address—
“(1)
how the Food and Drug Administration intends to simplify and streamline regulatory requirements for combination device and cell or tissue products;
“(2)
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;
“(3)
when the Food and Drug Administration considers it is necessary, if ever, for the intended use of a device to be limited to a specific intended use with only one particular type of cell; and
“(4)
application of the least burdensome approach to demonstrate how a device may be used with more than one cell type.
“(b)
Final Guidance.—
Not later than 12 months after the close of the period for public comment on the draft guidance under subsection (a), the Secretary of Health and Human Services shall finalize such guidance.”