FDA Updates Rules for Not Getting Diseases from Donated Body Parts
Published Date: 1/7/2025
Notice
Summary
The FDA just shared new draft guides to help companies that handle human cells and tissues keep dangerous viruses like Hepatitis B, Hepatitis C, and HIV from spreading. These updates make it clearer how to check donors and keep everyone safe. If you work in this field, you’ve got until February 6, 2025, to share your thoughts before the rules get finalized—so get ready to review and maybe adjust your processes!
Analyzed Economic Effects
4 provisions identified: 3 benefits, 1 costs, 0 mixed.
Remove MSM-specific donor questions
The FDA draft guidances recommend eliminating HCT/P donor screening questions that are specific to men who have sex with men (MSM) and women who have sex with MSM. Instead, donor eligibility should be assessed using the same individual risk‑based questions relevant to HBV, HCV, and HIV for every donor regardless of sex or gender.
Add HIV‑1 group O testing/screening
The draft guidance related to HIV explicitly recommends donor testing and screening for HIV‑1 group O risk as part of HCT/P donor eligibility assessments.
Reduce time-based screening factors
The draft guidances recommend revising donor screening to include reducing certain time-based risk factors and conditions when determining HCT/P donor eligibility. These revisions are part of updates intended to assist establishments making donor eligibility determinations.
No new paperwork requirements
The FDA states these draft guidances contain no new collection of information and refer to existing collections in 21 CFR part 1271.50 approved under OMB control number 0910-0139.
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