21 CFR § 1271.50 - How do I determine whether a donor is eligible?

---
identifier: "/us/cfr/t21/s1271.50"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 1271.50 - How do I determine whether a donor is eligible?"
title_number: 21
title_name: "Food and Drugs"
section_number: "1271.50"
section_name: "How do I determine whether a donor is eligible?"
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "L"
subchapter_name: "REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION"
part_number: "1271"
part_name: "HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "42 U.S.C. 216, 243, 263a, 264, 271."
regulatory_source: "66 FR 5466, Jan. 19, 2001, unless otherwise noted."
cfr_part: "1271"
---


# 1271.50 How do I determine whether a donor is eligible?

(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).