Description
We, FDA, 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, and cellular and tissue-based products (HCT/Ps).
Scope & Applicability
Product Classes
3Human cells, tissues, or cellular or tissue-based products defined in 21 CFR Part 1271
Infections were reported in recipients of these products.
The guidance provides recommendations to reduce the risk of transmission of disease agents associated with sepsis by HCT/Ps.
Stakeholders
2person to communicate with regarding patient's potential risk of sepsis
The individual at an HCT/P establishment who must determine and document donor eligibility.
Regulatory Context
Attributes
1state where immune system is weakened and unable to respond to infection
Identified Hazards
Hazards
2risk associated with sepsis in HCT/P donors
The guidance aims to reduce the risk of transmission of infections due to sepsis.
Related CFR Sections (4)
- 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 →
- 21CFR1271.3§ 1271.3 How does FDA define important terms in this part?
The following definitions apply only to this part: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 →
- 21CFR1271.50§ 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 →
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)
- Revised Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products Who Have Received Human-Derived Clotting Factor Concentrates: Guidance for Industry (Status: Final)
- 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 to Reduce the Risk of Transmission of Human Immunodeficiency Virus (HIV) by 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)
- 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 Mycobacterium tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Draft Guidance for Industry (Status: Draft)
- Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Guidance for Industry (Status: Final)