Yesterday the FDA issued a guidance document to help laboratories and manufacturers developing diagnostics for the novel coronavirus. The document, “Policy for Diagnostic Tests for Coronavirus Disease -2019 during the Public Health Emergency”, establishes a policy that aims to expedite the availability of tests for COVID-19. Due to the fact that this is a public health emergency, the FDA is implementing the guidance without prior public comment.
The guidance document is available for download immediately. FDA notes that this document supersedes “Policy for Diagnostics Testing in Laboratories Certified to Perform High-Complexity Testing under Clinical Laboratory Improvement Amendments (CLIA) prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency”, which was issued on February 29.