21 CFR 1271.50: How do I determine whether a donor is eligible?
Requires the establishment responsible for donor eligibility to have a responsible person document that a donor is eligible only if screening shows no relevant communicable disease or xenotransplantation risks and required tests are negative or nonreactive.
Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products · Subpart C, Donor Eligibility
How FDA words it
The opening lines investigators use most when they cite 1271.50, from the 483s we hold.
The eligibility of an HCT/P donor was not determined and documented by a responsible person, based on results of donor screening and donor testing.Most used
HCT/P donors were not determined to be eligible based on the results of donor screening and testing.1271.50(a)
Cited over time
483s citing 1271.50, by yearMost citations in 2025. Bars are relative to the busiest year. *2026 to date.
Years shown: 2017 to 2026. The busiest year was 2025.
Recent 483s citing 1271.50
- Americord Registry LLC · Somerset, New JerseyThe eligibility of an HCT/P donor was not determined and documented by a… Nov 17, 2025
- DCI Donor Services, Inc. · —Donors were not determined to be ineligible that had risk factors or clinical… Aug 28, 2025
- Conceive Fertility Center · Dallas, TexasThe eligibility of an HCT/P donor was not determined and documented by a… Jun 13, 2025
- MFC Lab, Inc. · —The eligibility of an HCT/P donor was not determined and documented by a… Apr 30, 2025
- Form 483 · FEI 3007268508 · Fort Worth, TexasThe eligibility of an HCT/P donor was not determined by a responsible person, based… Apr 24, 2025
The regulation text
§ 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).
Questions
What does 21 CFR 1271.50 require?
Requires the establishment responsible for donor eligibility to have a responsible person document that a donor is eligible only if screening shows no relevant communicable disease or xenotransplantation risks and required tests are negative or nonreactive.
How do FDA investigators word a 1271.50 observation?
The most common opening is: “The eligibility of an HCT/P donor was not determined and documented by a responsible person, based on results of donor screening and donor testing.”
Which sections are cited alongside 1271.50?
In the same 483s, investigators most often also cite 1271.47 (What procedures must I establish and maintain?), 1271.75 (How do I screen a donor?), 1271.80 (What are the general requirements for donor testing?), 1271.85 (What donor testing is required for different types of cells and tissues?).