Covid-19 Molecular Diagnostic Testing — Lessons Learned - The New England Journal of Medicine
On February 4, 2020, the U.S. secretary of health and human services declared that emergency use of diagnostics for SARS-CoV-2 was justified, triggering emergency authority for the Food and Drug Administration (FDA) to grant an emergency use authorization (EUA) for a device if it reasonably believes that it may be effective, rather than waiting to grant full approval when it has reasonable assurance that the device is safe and effective. This mechanism expedites access to accurate diagnostic tests during emergencies, when information gaps and false results may adversely affect patient care and public health decision making.
The EUA process enabled molecular diagnostic tests to be developed, validated, and deployed within weeks rather than several months to over a year, as traditionally required. In January, the agency had begun engaging with commercial manufacturers of diagnostic test kits and laboratories to help foster test development. To streamline submissions, the agency developed an EUA template with recommendations on validating a molecular diagnostic test for SARS-CoV-2 and outlined the required information. By July 31, the FDA had authorized 163 Covid-19 diagnostic tests.