Sunday, November 21, 2004
On Nov. 18, the FDA announced publication 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." The final rule is here and will be published in the Federal Register soon.
All tissue-related FDA documents are collected on this web page. The FDA describes its previous final rules this way: "[T]he agency has published two final rules and one interim final rule to implement aspects of the proposed approach. On January 19, 2001, we issued regulations to create a new, unified system for registering HCT/P establishments and for listing their HCT/Ps (registration final rule, 66 FR 5447). Part of the definition of 'human cells, tissues, or cellular or tissue-based products' became effective on January 21, 2004. On January 27, 2004 (69 FR 3823), we issued an interim final rule to except human dura mater and human heart valve allografts from the scope of that definition until all of the tissue rules became final. On May 25, 2004, we issued regulations requiring most cell and tissue donors to be tested and screened for relevant communicable diseases (donor-eligibility final rule, 69 FR 29786)."