What CHARTER Tri-Agency Task Force for Emergency Diagnostics requires
The Tri-Agency Task Force for Emergency Diagnostics (TTFED), with members from Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and Centers for Medicare and Medicaid Services (CMS), is established to develop a process to collaborate on future emergency diagnostic response needs. During emergencies, the TTFED will convene quickly to provide timely recommendations to laboratories for rapid implementation of in vitro diagnostic (IVD) assays authorized for use under FDA’s Emergency Use Authorization (EUA) authority. During public health emergencies, it is critical for IVD assays to be implemented quickly into clinical and public health laboratories for rapid patient care, and laboratories need clear guidance on the application of Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations for these assays. Through the TTFED, the agencies intend to coordinate the implementation of EUA IVD assays in laboratories within the U.S. healthcare system, with the ultimate goal of improving responses to public health emergencies. The TTFED was created to facilitate the use of any authorized EUA IVD assay and provide a platform to coordinate efforts to identify, establish and implement approaches to effectively and efficiently communicate. This work will occur through biannual meetings at a minimum, with the task force providing a forum for discussion of agent- or response-specific EUA IVD assays to help facilitate rapid implementation during an emergency.
Pillar: Food & Hospitality · Authority: Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and Centers for Medicare and Medicaid Services (CMS) · Version: 1.0.0 · Last updated:
Primary source: https://www.fda.gov/media/120328/download
SHA-256 integrity: d1a7e72e643614eed80fd0264986560e748778b29d47b886181683126e17f4fa
Primary Citations — 9 traced to source
- {"citation":"Authority","text":"The Tri-Agency Task Force for Emergency Diagnostics (TTFED) with members from Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and Centers for Medicare and Medicaid Services (CMS) is established to develop a process to collaborate on future emergency diagnostic response needs."}
- {"citation":"Background","text":"In addition, section 564 of the FFDCA authorizes FDA to issue an EUA for emergency use of an unapproved product or an unapproved use of an approved product."}
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