- June 04, 2019
The Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS) will collaborate on the regulatory response to threats, such as the Ebola and Zika viruses and other infectious diseases, both in the U.S. and abroad. “Bacteria and viruses don’t respect territorial boundaries,” said Jeffrey Shuren, Director of the FDA’s Center for Devices and Radiological Health (CDRH) in an Agency statement. “It takes a sustained, robust and globally coordinated effort to protect our nation and the global community from various infectious disease threats.”
“We also believe that this task force could lead to more innovation for diagnostic tests as developers will see a more predictable federal regulatory response through the agencies’ coordination,” Shuren added.
Unapproved diagnostics or product uses can be made available during a crisis through the FDA’s Emergency Use Authorization process, after meeting certain criteria. The Agency will work with any public or private diagnostic developer, including commercial companies, the CDC and the Department of Defense (DOD). The CDC would then be responsible for providing subject-matter expertise and epidemiological guidance to clinicians and laboratories responding to the emergency, as well as developing its own assays.
Meanwhile, CMS would maintain it’s authority over lab quality testing under the Clinical Laboratory Improvement Amendments’ (CLIA) standards — which are not exempt under an emergency use authorization. According to the Agencies, the clinical laboratory community was previously uncertain about how to deploy diagnostic tests after receiving an emergency authorization — specifically on meeting CLIA regulations before testing specimens during a crisis.
“During public health emergencies, ensuring the health and safety of patients through quality laboratory testing will remain the focus of CMS,” said CMS Chief Medical Officer Kate Goodrich, Director of the Center for Clinical Standards and Quality. “As part of this task force, it is our goal to provide clear and consistent guidance to laboratories on the application of CLIA requirements for these emergency assays.”
The task force will meet twice a year, with additional meetings as needed, and will be convened during any relevant public health emergency.
REFERENCE: Fierce MedTech; 27 FEB 2019; Conor Hale