Exemptions and Alternative Procedures

Per 21 CFR 1271.155, an HCT/P establishment may request an exemption or alternative procedure to any Donor Eligibility and/or Current Good Tissue Practices regulation. The request for exemption or alternative procedure must be submitted to the appropriate center director at the FDA; however, CBER has redelegated the authority to issue a response to the director and deputy director of the Office of Cellular, Tissue and Gene Therapies. The request must include supporting documentation, including all relevant valid scientific data, and must contain either information justifying the requested exemption from the requirement or a description of a proposed alternative method of meeting the requirement. Additional information on requesting an exemption or alternative procedure is available.