21 C.F.R. § 1271.50 How do I determine whether a donor is eligible?
Title 21 - Food and Drugs
(a) Determination based on screening and testing. If you are the establishment responsible for making the donor-eligibility determination, you must determine whether a donor is eligible based upon the results of donor screening in accordance with §1271.75 and donor testing in accordance with §§1271.80 and 1271.85. A responsible person, as defined in §1271.3(t), must determine and document the eligibility of a cell or tissue donor. (b) Eligible donor. A donor is eligible under these provisions only if: (1) Donor screening in accordance with §1271.75 indicates that the donor: (i) Is free from risk factors for, and clinical evidence of, infection due to relevant communicable disease agents and diseases; and (ii) Is free from communicable disease risks associated with xenotransplantation; and (2) The results of donor testing for relevant communicable disease agents in accordance with §§1271.80 and 1271.85 are negative or nonreactive, except as provided in §1271.80(d)(1).
Title 21: Food and Drugs
PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
Subpart C—Donor Eligibility
§ 1271.50 How do I determine whether a donor is eligible?
