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of Mycobacterium tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Draft Guidance for Industry

Description

We, FDA, are issuing this guidance to assist you, establishments making donor eligibility (DE) determinations,  in understanding the requirements in 21 CFR 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).   This guidance provides recommendations for screening donors for evidence of, and risk factors for, infection with Mycobacterium tuberculosis (Mtb), the organism that causes tuberculosis.  The guidance also recommends additional steps that HCT/P establishments should take to reduce risk of transmission of Mtb until such time as appropriate FDA-licensed, approved, or cleared donor screening tests are available for use to test donors for Mtb infection.

Scope & Applicability

Regulatory Context

• 21CFR1271.3§ 1271.3 How does FDA define important terms in this part?

  The following definitions apply only to this part:Read full regulation →

• 21CFR1271.50§ 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 →

• 21CFR630.3§ 630.3 Definitions.

  As used in this part and in part 610, subpart E, and part 640 of this chapter :Read full regulation →

• 21CFR866.3372§ 866.3372 Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens.

  (a) Identification. Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens are qualitative nucleic acid-based in vitro diagnostic devices intended to detect Mycobacterium tuberculosis complex nucleic acids extracted from human Read 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 →

• 21CFR1271.80§ 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 →

• 21CFR1271.160§ 1271.160 Establishment and maintenance of a quality program.

  (a) General. If you are an establishment that performs any step in the manufacture of HCT/Ps, you must establish and maintain a quality program intended to prevent the introduction, transmission, or spread of communicable diseases through the manufacture and use of HCT/Ps. The quality program must bRead full regulation →

• 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

  2025-12-16

• 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

  2025-12-09

• CGMP/QSR/Medical Devices/Adulterated/Misbranded

  Royal Philips

  2025-10-28

• CGMP/Deviations/Biologics License Application (BLA)

  New Life Medical Services, LLC

  2025-10-07

• Medical Device Reporting/Misbranded

  Insung Medical Co. Ltd.

  2025-09-30

• Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

  NuVida Medical LLC

  2025-09-16

• Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

  Platinum Biologics LLC

  2025-08-26

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