The FDA issued a new policy that will allow certain laboratories to use validated COVID-19 diagnostics before the agency has completed review of their Emergency Use Authorization (EUA) requests.
The agency also issued a final guidance that will allow the use of these tests for clinical testing while laboratories are pursuing an EUA. The new policy only applies to laboratories that are certified to perform high-complexity testing.
FDA Commissioner Stephen Hahn said the agency is not changing its standards for issuing Emergency Use Authorizations, but that the agency is “rapidly responding and adapting to this dynamic and evolving situation.”
CDRH Director Jeff Shuren said the agency is “dedicating all available resources to expediting the review of medical products, including diagnostics, to prevent the spread of this outbreak.