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The Food and Drug Administration (FDA) today announced the issuance of a final rule on current good tissue practice (GTP), the last of three rules to be finalized as part of the Agency's overall plan to make human cells and tissues even safer. GTP includes the methods, facilities and controls used to manufacture these products. With this final rule, FDA's efforts to establish a new, comprehensive, and risk-based approach to this promising and innovative field of medicine can be realized. The new approach will be fully implemented on May 25, 2005.
"Together, these three rules will improve public health and, equally important, increase confidence in these new technologies that hold such great promise for medical practice," said Dr. Lester M. Crawford, Acting FDA Commissioner. "In finalizing these rules, FDA considered comments from a broad range of groups, including those representing consumers, health professionals and industry. The breadth and complexity of the products being regulated required nothing less than our most serious deliberation."
The new rule, entitled "Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Establishments; Inspection and Enforcement," requires manufacturers to recover, process, store, label, package and distribute human cells, tissues and cellular and tissue-based products (HCT/Ps) in a way that prevents the introduction, transmission, or spread of communicable diseases. The regulations apply to a broad range of these products including musculoskeletal tissue, corneas, human heart valves, dura mater (lining of the brain) and cellular therapies.
The final GTP rule follows the earlier publication of FDA's final regulations on registration of human tissue establishments and the eligibility of human tissue donors. The rule also includes a requirement for manufacturers to report certain adverse reactions and HCT/P deviations, to have labeling that contains accurate and complete information, and to allow FDA inspections to ensure compliance with regulations.
Two other related proposed rules to implement the 1997 regulatory approach to tissues and cells have already been finalized. The first rule, "Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products," was finalized on January 19, 2001. It became fully effective on January 21, 2004, and requires tissue facilities to register with the FDA and list their products.
The other rule, "Suitability Determination for Donors of Human Cellular and Tissue-Based Products," was finalized on May 25, 2004, and focuses on donor screening and testing measures to prevent the unwitting use of contaminated tissues with potential to transmit infectious diseases. It will become effective on May 25, 2005, and applies to all HCT/Ps, including reproductive cells and tissues. This new GTP rule, which applies to all non-reproductive cells and tissues, also will become effective on May 25, 2005.
FDA's first regulations specifically addressing human tissues were promulgated in December 1993. These regulations required that tissue donors be tested for certain communicable diseases such as HIV and hepatitis, and screened for behavioral risk factors. The new regulations apply to a broader range of human cells, tissues, and cellular and tissue-based products and provide more comprehensive protections to prevent the transmission of communicable disease, including the flexibility to deal with new and emerging infectious disease threats.
Once the new regulations are all effective next year, they will apply to cellular and tissue-based products recovered on or after May 25, 2005. FDA's current rules will remain in effect for products recovered before that date.
Additional information about FDA's efforts to make the nation's tissue supply even safer is available online at www.fda.gov/cber/tissue/docs.htm.
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