To require the Secretary of Health and Human Services to treat certain tests for tuberculosis as breakthrough devices eligible for expedited development and priority review, to require certain establishments that perform donor screening or testing to screen or test for active and latent tuberculosis, and for other purposes.
This bill requires the federal government to accelerate approval of new tuberculosis screening tests for blood and tissue donors and to strengthen tuberculosis testing requirements across the donation industry. Specifically, the legislation designates innovative tuberculosis tests as "breakthrough devices" eligible for expedited FDA review, and it mandates that all facilities performing donor screening or testing check donors for both active and latent tuberculosis infections. The bill requires the Department of Health and Human Services to propose new regulations within one year of enactment and finalize them within three months after the public comment period closes, with implementation to begin within six months of finalization. The legislation also directs the FDA and Centers for Disease Control and Prevention to update industry guidance on tissue and cellular product manufacturing practices within six months. No new federal funding is authorized, as the bill must be carried out using existing agency resources.
Take Action
Your position
Add a comment
to comment on this bill.
Annotate the text
Highlight any passage on the Summary or Full Text tab to attach a note. Annotations appear on the Annotations tab.