Description
We, FDA, are issuing this guidance to assist you, establishments making donor eligibility determinations, with complying with the requirements in Title 21 Code of Federal Regulations, part 1271, subpart C (21 CFR part 1271, subpart C) (Ref. 1). 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
10HCT/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
HCT/Ps associated with septic arthritis
subject to testing or pathogen reduction
Subject of donor eligibility recommendations
donors of reproductive cells and tissues
Category requiring additional testing
donation of oocytes not undergoing cryopreservation
HPCs obtained from peripheral blood or bone marrow
Persons who are xenotransplantation product recipients or intimate contacts
Example of HCT/Ps collected by venipuncture.
Stakeholders
10Entities that collect Whole Blood or blood components
Potential HCT/P donor screening
Entities responsible for manufacture and labeling of CSP; Must follow instructions for use provided by the device manufacturer; Blood establishments that manufacture licensed blood components
Recipient of embryos in a reproductive setting
Allowed value for reporter qualification
Partner of the recipient; exempt from certain donor eligibility determinations.
Donors known to the recipient, subject to different testing/quarantine rules.
donor type subject to specific quarantine and retesting
Professional required for dura mater donor assessment
must be notified of low post-collection platelet counts
Regulatory Context
Attributes
8Condition affecting the validity of donor specimens for testing.
Calculated parameter based on donor weight used in the algorithm.
Calculated parameter based on donor weight used in the algorithm.
prominent labeling requirement for ineligible donors
Cells and tissue intended for the same individual from whom they were recovered.
Condition where infused fluids make a specimen unacceptable for testing.
Collection of documents including history, physical assessment, and other records
criteria an HCT/P must meet for distribution
Identified Hazards
Hazards
8potential for disease transmission via HCT/P
viremic donations were removed from the blood supply
hazard associated with animal food facilities
Risk factor in platelet storage; Risk controlled by cold storage; control the risk of bacterial contamination for up to 14 days
risk of zoonotic transmission from this product is minimal
A viral infection listed as a risk factor for donor ineligibility.
A viral infection listed as a risk factor for donor ineligibility.
Human Immunodeficiency Virus transmission risk
Related CFR Sections (15)
- 21CFR640.120§ 640.120 Alternative procedures.
(a) The Director, Center for Biologics Evaluation and Research, may issue an exception or alternative to any requirement in subchapter F of chapter I of title 21 of the Code of Federal Regulations regarding blood, blood components, or blood products. The Director may issue such an exception or alterRead full regulation →
- 21CFR1271.65§ 1271.65 How do I store an HCT/P from a donor determined to be ineligible, and what uses of the HCT/P are not prohibited?
(a) Storage. If you are the establishment that stores the HCT/P, you must store or identify HCT/Ps from donors who have been determined to be ineligible in a physically separate area clearly identified for such use, or follow other procedures, such as automated designation, that are adequate to prevRead 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 →
- 21CFR1271.55§ 1271.55 What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?
(a) Accompanying records. Once a donor-eligibility determination has been made, the following must accompany the HCT/P at all times:Read full regulation →
- 21CFR1271.15§ 1271.15 Are there any exceptions from the requirements of this part?
(a) You are not required to comply with the requirements of this part if you are an establishment that uses HCT/P's solely for nonclinical scientific or educational purposes.Read full regulation →
- 21CFR1271.45§ 1271.45 What requirements does this subpart contain?
(a) General. This subpart sets out requirements for determining donor eligibility, including donor screening and testing. The requirements contained in this subpart are a component of current good tissue practice (CGTP) requirements. Other CGTP requirements are set out in subpart D of this part .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 →
- 21CFR1271.85§ 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 →
- 21CFR1271.80§ 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 →
- 21CFR1271.150§ 1271.150 Current good tissue practice requirements.
(a) General. This subpart D and subpart C of this part set forth current good tissue practice (CGTP) requirements. You must follow CGTP requirements to prevent the introduction, transmission, or spread of communicable diseases by HCT/Ps (e.g., by ensuring that the HCT/Ps do not contain communicable Read full regulation →
- 21CFR1271.1§ 1271.1 What are the purpose and scope of this part?
(a) Purpose. The purpose of this part, in conjunction with §§ 207.9(a)(5) , 210.1(c) , 210.2 , 807.20(d) , and 820.1(a) of this chapter , is to create an electronic registration and listing system for establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/PRead full regulation →
- 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 →
- 21CFR1271.47§ 1271.47 What procedures must I establish and maintain?
(a) General. You must establish and maintain procedures for all steps that you perform in testing, screening, determining donor eligibility, and complying with all other requirements of this subpart. Establish and maintain means define, document (in writing or electronically), and implement; then foRead 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 →
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- 2025-08-26
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See Also (8)
- Classification of Products as Drugs and Devices and Additional Product Classification Issues: Guidance for Industry and FDA Staff (Status: Final)
- Validation of Procedures for Processing of Human Tissues Intended for Transplantation: Guidance for Industry (Status: Final)
- Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Guidance for Industry (Status: Final)
- Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection: Guidance for Industry (Status: Final)
- Compliance with 21 CFR Part 1271.150(c)(1) – Manufacturing Arrangements: Guidance for Industry (Status: Final)
- Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs): Guidance for FDA Reviewers and Sponsors (Status: Final)
- Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing (Status: Final)
- Considerations for Allogeneic Pancreatic Islet Cell Products: Guidance for Industry (Status: Final)