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Today's action is part of FDA's implementation of a new comprehensive regulatory framework, announced in 1997, designed to help ensure the safety and quality of products, including new technologies, without imposing unnecessary regulatory requirements.

"We must ensure that our regulation of human tissues and cells keeps pace with the rapid growth of technology in this field," said HHS Secretary Donna E. Shalala. "Patients can greatly benefit from these new uses of cells and tissues, but FDA must be able to know the scope of the industry to better regulate and communicate with the industry."

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 disease. Other tissue-related products will be required to obtain premarket approval in addition to following the communicable disease requirements.

"This rule will give the FDA the information it needs to implement the agency's risk-based approach to tissue regulation," said Commissioner of Food and Drugs, Jane E. Henney, M.D.

The new tissue rule covers a broad array of cells and tissues, such as skin, tendons, bone, heart valves, and corneas, which have long been used to repair or replace damaged or diseased tissues. The new rule also applies 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 new rule also covers tissues that have not been regulated before including reproductive tissues and stem cells derived from umbilical cord blood and other blood sources. Tissue establishments already regulated by FDA have 105 days to comply with the new rule, whereas establishments of newly regulated human cells and tissues will have two years to put its provisions into effect.

FDA is not requiring registration and listing by establishments that:

*use cells and tissues solely for nonclinical scientific or educational purposes;

*remove cells and tissues and transplant them into the same person in a single surgical procedure;

*deliver cells or tissues in the usual course of business;

*recover reproductive cells or tissue and immediately transfer them into a sexually intimate partner of the donor;

*receive or store cells or tissues solely for use within a single facility.

FDA earlier proposed two other related rules to implement the 1997 regulatory approach. One ("Suitability Determination for Donors of Human Cellular and Tissue-Based Products") was issued on Sept. 30, 1999, and focuses on donor screening and testing measures to prevent the unwitting use of contaminated tissues with the potential to transmit infectious diseases. The other one ("Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based Products; Inspection and Enforcement") was issued Jan. 8, and would establish good tissue practice standards for the methods, facilities and controls used to manufacture these products.

FDA's current regulations addressing tissues were promulgated in December 1993 as an interim final rule that required the screening and testing of tissue donors for certain transmissible diseases such as HIV infection and hepatitis. The interim final rule was made final with minor changes on July 29, 1997, and took effect on Jan. 26, 1998.

The two proposed rules, once they are made final, and today's rule on registration and listing will provide a more comprehensive, risk-based regulatory approach and include provisions for the regulation of innovative products.

It is expected that all three rules of the 1997 regulatory approach will be finalized within the next two years.

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