---
kind: "section"
citation: "21 C.F.R. § 1271.50"
title: "21"
number: "1271.50"
heading: "How do I determine whether a donor is eligible?"
url: "https://uscodex.org/cfr/21/1271.50"
---

# §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](/cfr/21/1271.75.md) and donor testing in accordance with §§ [1271.80](/cfr/21/1271.80.md) and [1271.85](/cfr/21/1271.85.md). A responsible person, as defined in [§ 1271.3(t)](/cfr/21/1271.3.md?p=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](/cfr/21/1271.75.md) 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](/cfr/21/1271.80.md) and [1271.85](/cfr/21/1271.85.md) are negative or nonreactive, except as provided in [§ 1271.80(d)(1)](/cfr/21/1271.80.md?p=d-1).

## Notes

### Source

Source: 69 FR 29830, May 25, 2004, unless otherwise noted.

### Authority

Authority: 42 U.S.C. 216, 243, 263a, 264, 271.

### Source

Source: 66 FR 5466, Jan. 19, 2001, unless otherwise noted.