{"data":{"id":"us/21-cfr-1271.50","jurisdiction":"us","citation":"21 CFR 1271.50","heading":"How do I determine whether a donor is eligible?","body":"(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.\n(b) Eligible donor. A donor is eligible under these provisions only if:\n(1) Donor screening in accordance with § 1271.75 indicates that the donor:\n(i) Is free from risk factors for, and clinical evidence of, infection due to relevant communicable disease agents and diseases; and\n(ii) Is free from communicable disease risks associated with xenotransplantation; and\n(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).","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER L—REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION","PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS","Subpart C—Donor Eligibility"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"6cd8d20defd400ac2115bbb765a696371d4249d6df0f440cfc86c9f53e517368","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-1271.47","next":"us/21-cfr-1271.55"},"notice":"GroundRules: Original legal text. Not legal advice."}