US FDA final reg for tissue banks

The US Food and Drug Administration has this month issued a finalregulation requiring all manufacturers of human cells, tissues and cellular and tissue-based products to register and list the products with the agency. When the regulation is fully implemented, it will provide, for the first time, a complete base of information on the tissue bank industry, including certain cells and tissues that were not previously regulated.

The new rule is part of the FDA's comprehensive regulatory framework, first announced in 1997, which is designed to help ensure product safety and quality, including new technologies, without imposing unnecessary regulatory requirements. According to FDA Commissioner Jane Henney, it will "give the FDA the information it needs to implement the agency's risk-based approach to tissue regulation."

The new rule establishes a tiered system of regulation, under which certain tissues and cells will be subject only to regulations aimed at preventing the spread of communicable diseases. Other tissue-related products will be required to obtain premarket approval, as well as following the communicable disease requirements.