Description
We, FDA or Agency, are issuing this guidance to assist you, establishments making donor eligibility determinations, in understanding the requirements in Title 21 Code of Federal Regulations, part 1271, subpart C (21 CFR part 1271, subpart C). The regulations under 21 CFR part 1271, subpart C set out requirements for determining donor eligibility, including donor screening and testing, for donors of human cells, tissues, or cellular or tissue-based products (HCT/Ps).
Scope & Applicability
Product Classes
7The guidance provides recommendations to reduce the risk of transmission of disease agents associated with sepsis by HCT/Ps.
subject to testing or pathogen reduction
Blood component subject to the recommendations in this guidance
HCT/Ps are the primary products covered by this guidance.; Guidance regarding the reduction of HBV transmission risk in HCT/Ps.; Products for which HBV transmission risk recommendations are provided
Products through which HIV transmission has been documented.
Organs through which HIV transmission has been documented.
Human cells, tissues, or cellular or tissue-based products defined in 21 CFR Part 1271
Stakeholders
7The entities responsible for following the screening and testing requirements.
Risk Factors for Semen Donation
Preventing disease transmission by deceased tissue donors
Potential HCT/P donor screening
Men who have sex with men
donor type subject to specific quarantine and retesting
donor type with elective quarantine and retesting options
Regulatory Context
Attributes
2Recommended time-based deferral for certain risk factors
Status of an organ and tissue donor who transmitted HIV-1
Identified Hazards
Hazards
2Human Immunodeficiency Virus transmission risk
Preventing Transmission of HIV Through Transplantation of Human Tissue and Organs
Related CFR Sections (7)
- 21CFR1271.75§ 1271.75 How do I screen a donor?
(a) All donors. Except as provided under § 1271.90 , if you are the establishment that performs donor screening, you must screen a donor of cells or tissue by reviewing the donor's relevant medical records for:Read full regulation →
- 21CFR1271.80§ 1271.80 What are the general requirements for donor testing?
(a) Testing for relevant communicable diseases is required. To adequately and appropriately reduce the risk of transmission of relevant communicable diseases, and except as provided under § 1271.90 , if you are the establishment that performs donor testing, you must test a donor specimen for evidencRead full regulation →
- 21CFR1271.50§ 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 and donor testing in accordance with §§ 127Read full regulation →
- 21CFR1271.3§ 1271.3 How does FDA define important terms in this part?
The following definitions apply only to this part:Read full regulation →
- 21CFR1271.85§ 1271.85 What donor testing is required for different types of cells and tissues?
(a) All donors. To adequately and appropriately reduce the risk of transmission of relevant communicable diseases, and except as provided under § 1271.90 , you must test a specimen from the donor of cells or tissue, whether viable or nonviable, for evidence of infection due to relevant communicable Read full regulation →
- 21CFR1271.90§ 1271.90 Are there other exceptions and what labeling requirements apply?
(a) Donor-eligibility determination not required. You are not required to make a donor-eligibility determination under § 1271.50 or to perform donor screening or testing under §§ 1271.75 , 1271.80 and 1271.85 for:Read full regulation →
- 21CFR1271.60§ 1271.60 What quarantine and other requirements apply before the donor-eligibility determination is complete?
(a) Quarantine. You must keep an HCT/P in quarantine, as defined in § 1271.3(q) , until completion of the donor-eligibility determination required by § 1271.50 . You must quarantine semen from anonymous donors until the retesting required under § 1271.85(d) is complete.Read full regulation →
Related Warning Letters (10)
- 2025-12-16
CGMP/Deviations/Biologics License Application (BLA)
Microvascular Tissue, Inc.
- 2025-12-16
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
Green Valley Fertility Partners
- 2025-12-09
Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)
BioXtek LLC
- 2025-12-09
Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)
Celularity, Inc
- 2025-12-09
Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)
Lux Therapeutics LLC dba Ponya Therapeutics LLC
- 2025-10-07
CGMP/Deviations/Biologics License Application (BLA)
New Life Medical Services, LLC
- 2025-09-16
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
NuVida Medical LLC
- 2025-08-26
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
Platinum Biologics LLC
- 2025-08-26
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
Innate Healthcare Institute
- 2025-07-01
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
InVia Fertility Specialists, PLLC
See Also (8)
- Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products: Guidance for Industry (Status: Final)
- Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products: Guidance for Industry (Status: Final)
- Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271: Guidance for Industry (Status: Final)
- Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs): Guidance for Industry (Status: Final)
- Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products (Status: Draft)
- Recommendations to Reduce the Risk of Transmission of Hepatitis C Virus (HCV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Draft Guidance for Industry (Status: Draft)
- Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Draft Guidance for Industry (Status: Draft)
- Recommendations to Reduce the Risk of Transmission of Hepatitis B Virus (HBV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Draft Guidance for Industry (Status: Draft)