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# FDA Update on Bone Matrix TB Issue
- URL: https://www.fdaweb.com/fda-update-on-bone-matrix-tb-issue/
- Published: 2023-09-07T12:00:00.000Z
- Updated: 2026-09-14T18:55:00.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5155273

FDA says it is working closely with the Centers for Disease Control and Prevention to investigate reports of a tuberculosis (TB) outbreak caused by *Mycobacterium tuberculosis* that appears to be linked to a bone matrix product. An agency online [post](https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/important-information-human-cell-tissue-and-cellular-and-tissue-based-product-hctp-establishments-1?ref=fdaweb.com) outlines risk mitigation strategies for human cell, tissue, and cellular and tissue-based product (HCT/P) establishments.

The post says the HCT/P establishment’s responsible person under regulations must determine and document the eligibility of a cell or tissue donor.

Although tuberculosis may be undiagnosed due to the lack of clinical suspicion, inherent diagnostic difficulty, and/or attribution of a group of symptoms to alternate causes, FDA lists factors it says establishments may want to consider regarding HCT/P donors.

The agency also says that although there are currently no FDA-licensed, cleared, or approved donor screening tests available with an indication to screen HCT/P donors for evidence of active TB or latent tuberculosis infection, FDA is evaluating the risks and appropriate mitigation strategies, including testing.