FDA Proposes New Framework for Regenerative Medicine and Combo Products

The FDA’s newly unveiled regenerative medicine framework contains guidance on when premarket review is required and how to expedite agency review — as well as a draft guidance on how devices used in the recovery, isolation and delivery of therapies will be evaluated as combination products.

Commissioner Scott Gottlieb said the field’s rapid growth and complexity presents unique challenges to researchers, providers and the FDA — with more and more products being subject to premarket review.

Combination products based on regenerative medicine advanced therapies, or RMATs, are generally reviewed under a single application, even if the RMAT and a specified delivery device are separately packaged but labeled for use together.

The draft details the attributes and intended uses that would result in a product being labeled a Class III device — although the agency says it has no predetermined list — and when a device may be limited to a specific intended use with only one particular type of cell.