The Food and Drug Administration on Friday published a final regulation requiring all establishments that manufacture human cells, tissues, and cellular and tissue-based products to register and list their products with the agency. When this 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.
Friday'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
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
- *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
It is expected that all three rules of the 1997 regulatory approach will be
finalized within the next two years.