When did the current good tissue practice final rule become effective?
The good tissue practice rule became effective on May 25, 2005. What regulatory changes occurred on May 25, 2005? Human heart valve allografts and human dura mater allografts were previously regulated as medical devices. Human heart valve allografts and human dura mater allografts are now regulated solely as HCT/Ps under section 361 of the Public Health Service Act assuming they meet the criteria in section 1271.10(a). The January 27, 2004 Interim Final Rule, which previously regulated these products as medical devices, has been revoked. Do the requirements in the current good tissue practice rule apply to HCT/Ps recovered before the effective date? The requirements apply to HCT/Ps recovered on or after the effective date. We have amended part 1270 by modifying the definition of human tissue intended for transplantation [1270.3(j)] to limit its applicability to tissue collected before May 25, 2005. Did FDA already have requirements for current good tissue practice prior to the effectiv
