The FDA has formulated a comprehensive approach to the regulation of human cellular and tissue-based products. This approach would provide more appropriate oversight for the wide spectrum of cellular and tissue-based products that are now marketed or envisioned for the future. It would maintain or improve protection of the public and increase public confidence in these new technologies, while permitting significant innovation to go forward unfettered by unnecessary regulatory requirements.

The approach does not encompass vascularized organs or minimally-manipulated bone marrow (both of which are regulated by the Health Resources and Services Administration), transfusable blood products (e.g., whole blood, red blood cells, platelets, and plasma), which the agency already comprehensively regulates,1 or tissues derived from animals.2 It also does not encompass other tissue-related products, such as products used in the propagation of cells or tissues, or that are secreted by or extracted from cells or tissues (e.g. human milk, collagen, urokinase, cytokines, and growth factors.) Such products often raise different manufacturing, safety, and effectiveness issues, and generally are covered by other rules, regulations, and/or standards.

Questions?