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Code of Federal Regulations Title 21. Food and Drugs § 21.1271.50 How do I determine whether a donor is eligible?

Current as of January 02, 2025 | Updated by Findlaw Staff

(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).

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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.1271.50 How do I determine whether a donor is eligible? - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-1271-50/

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