 |
Current Good Tissue Practice (GTP) for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments
November 24, 2004
"This rule represents the culmination of FDA’s efforts to establish a comprehensive new system for regulating HCT/Ps. The regulations now being issued require certain HCT/Ps to be manufactured in compliance with CGTP. The rule also contains provisions relating to establishment inspection and enforcement, as well as certain labeling and reporting requirements, which are applicable to those HCT/Ps regulated solely under the authority of section 361 of the PHS Act (42 U.S.C. 264) and the regulations in part 1271 (21 CFR part 1271), and not as drugs, devices, and/or biological products under the Federal Food, Drug, and Cosmetic Act (the act)."
21 CFR Parts 16, 1270, and 1271 Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue- Based Product Establishments; Inspection and Enforcement; Final Rule
|
|
|
|
