FDA withdraws two final guidances, pulls compliance deadlines for bone allograft makers
Title
FDA Withdraws Guidances and Compliance Deadlines for Bone Allograft Manufacturers Amid Industry Pushback
Keywords
- FDA guidance withdrawal
- bone allograft compliance
- cell- and tissue-based products
- donor eligibility
- sepsis and tuberculosis outbreaks
- medical device regulation
- Mycobacterium tuberculosis (MTB)
- tissue safety standards
- Eye Bank Association of America (EBAA)
- American Association of Tissue Banks (AATB)
Key Facts
- The FDA has withdrawn two final guidance documents and associated compliance deadlines for manufacturers of bone allografts and other cell- and tissue-based medical products.
- These guidances were intended to provide clearer standards for donor eligibility and enhance the safety of tissue transplants, particularly after significant outbreaks of Mycobacterium tuberculosis (MTB) linked to bone allograft products in the US in 2021 and 20234.
- The 2021 MTB outbreak resulted in significant morbidity, three deaths, and secondary infections among healthcare workers. Another outbreak in 2023 led to further infections and fatalities4.
- Industry groups, such as the Eye Bank Association of America (EBAA) and Artivion, Inc., formally requested the rescission of these guidances, arguing that the requirements were overly burdensome, lacked sufficient clinical input, and overlapped with new standards developed by the AATB to address safety concerns more effectively15.
- The FDA’s withdrawal of the guidances suspends the planned compliance deadlines and signals a willingness to reconsider regulatory approaches for tissue safety in response to stakeholder concerns and evolving standards within the tissue banking industry5.
Sources:
1. https://restoresight.org/wp-content/uploads/2025/01/Jan-15-2025-EBAA-Response-to-FDAs-Sepsis-and-Mtb-Final-Guidance.pdf
4. https://restoresight.org/news/regulatory-alert-fda-inspectional-focus-on-donor-eligibility-with-regard-to-sepsis/
5. https://downloads.regulations.gov/FDA-2024-D-3863-0143/attachment_1.pdf