Emergency diagnostics news

Emergency diagnostics news

FDA, CDC, and CMS launch task force to help facilitate rapid availability of diagnostic tests during public health emergencies

On February 26, 2019, FDA, the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS) announced the launch of the Tri-Agency Task Force for Emergency Diagnostics. This task force has been created to help leverage the expertise of each agency to advance rapid development and deployment of diagnostic tests in clinical and public health laboratories during public health emergencies. Also see: Charter: Tri-Agency Task Force for Emergency Diagnostics (PDF, 196 KB)

New web pages

Information for Laboratories Implementing IVD Tests Under EUA This page is intended for laboratories that are implementing in vitro diagnostic (IVD) assays (tests) under an Emergency Use Authorization (EUA) and will help laboratories using tests available under EUA learn more about the benefits and limitations of EUA tests, and answer frequently asked questions, including how to report problems with a EUA test to FDA during an emergency. How to Submit a Pre-EUA for In vitro Diagnostics to FDA   To help prepare for potential and current emergencies, FDA works with medical countermeasure developers to prepare Pre-EUA packages, when appropriate. A Pre-EUA package contains data and information about the safety, quality, and efficacy of the product, its intended use under a future or current EUA, and information about the emergency or potential emergency situation. This page is intended for manufacturers of IVD tests.