New FDA Regulations Require Registration of Cell and Tissue Products

The FDA yesterday released final regulations requiring all establishments that manufacture human cells, tissues and cellular- and tissue-based products to register and list their products with the agency. The new requirements will create for the first time a "complete base of information on the tissue bank industry," and will include tissues and cells not previously regulated. The rules also establish a tiered system of regulation, under which certain tissues and cells will be "subject only to regulations aimed at preventing the spread of communicable disease," while other tissue-related products will be "required to obtain premarket approval in addition to following the communicable disease requirements." FDA Commissioner Jane Henney said, "This rule will give the FDA the information it needs to implement the agency's risk-based approach to tissue regulation" (FDA release, 1/18). Earlier this month, an HHS report found that many U.S. tissue banks have "never been inspected by federal authorities, leaving tissue recipients potentially vulnerable to infection from HIV, hepatitis and other pathogens" (Kaiser Daily HIV/AIDS Report, 1/10). The new FDA regulations cover a "broad array" of cells and tissues, including skin, tendons, bone, heart valves and corneas, and encompass tissues that have not been previously subjected to regulation, including reproductive tissues and stem cells derived from "umbilical cord blood and other blood sources." The rules also apply to "novel uses" under development for human cells and tissues, such as the use of "manipulated human cells" to treat viral infections, Parkinson's disease and diabetes. The FDA has proposed two other related rules concerning tissue regulation. A 1999 guideline focuses on donor screening and testing measures for infectious diseases, and a guideline issued Jan. 8 aims to create "good tissue practice standards" for the methods, facilities and controls used to manufacture cellular and tissue-based products. All three regulations are expected to be finalized within the next two years (FDA release, 1/18).