FDA clarifies pathway for devices used in regenerative medicine
- The Food and Drug Administration on Friday issued final guidance for the development of regenerative medicine therapies such as cell or tissue products, saying the treatments have the potential to address "hundreds of vexing human diseases and conditions."
- The guidance addresses device classification for determining the pre-market pathway as well as when a device may be labeled for use with a specific regenerative medicine or class and when a device may be limited to use with only one type of cell.
- The document finalizes draft guidance first issued in November 2017.
The regenerative medicine field includes tissue engineering, which involves developing biological substitutes that can restore or improve damaged tissues and organs.
The FDA has approved artificial skin and cartilage, but the use of such products is limited, according to the National Institute of Biomedical Imaging and Bioengineering. Regenerative medicine also incorporates self-healing in which the body uses its own systems, sometimes in conjunction with biological materials, to recreate cells and rebuild tissues.
In its guidance, the agency refers to instruments, machines and implants used in the recovery, isolation or delivery of the treatments. A regenerative medicine therapy is defined as intended to treat or cure a serious or life-threatening condition.
"We're providing information to product developers regarding how the agency intends to evaluate devices used with regenerative medicine advanced therapies, as well as providing information on the expedited development programs that may be available to regenerative medicine therapies targeted to serious conditions," FDA Commissioner Scott Gottlieb said in a statement.
The FDA said a wide range of devices can be used in conjunction with a regenerative medicine advanced therapy. These can include a simple low-risk device, such as a scalpel for recovering cells and tissue, or a complex device such as an automated cell collection system that selects and processes specific cells intended for immediate return back to the patient.
In discussing combination products, the agency said devices intended for use with a specific regenerative medicine may, together with the treatment, be considered a biologic-led combination product and therefore evaluated for marketing under a Biologics License Application.
The FDA introduced a regenerative medicine policy framework in 2017 to support product development in cell-based and gene therapies.
At that time, the agency issued two final guidances addressing when a product is subject to the premarket review pathway. It also issued two draft guidances, one dealing with devices used with regenerative medicine advanced therapies and the other describing programs for expediting development of the treatments.