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Code · CFR · Title 21 — Food and Drugs · Part 1271 — Human Cells, Tissues, and Cellular and Tissue-Based Products · § 1271.50

§ 1271.50. How do I determine whether a donor is eligible?

152 words·~1 min read·/us/cfr/t21/s§ 1271.50

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(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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§ 1271.50
How do I determine whether a donor is eligible?
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