March 4, 2020—The FDA issued on Feb. 29 a new policy for certain laboratories seeking to develop diagnostic tests for coronavirus in order to achieve more rapid testing capacity in the U.S.
The policy is for certain laboratories that develop and begin to use validated COVID-19 diagnostics before the FDA has completed review of their emergency use authorization requests. It also describes the circumstances in which the FDA does not intend to object to the use of these tests for clinical testing while the laboratories are pursuing an EUA with the FDA. The policy applies only to laboratories that are certified to perform high-complexity testing consistent with requirements under CLIA. Recommendations for test developers, including information regarding test validation, FDA notification, and interim confirmatory clinical testing are also provided in the guidance.
“We applaud the FDA’s approach to speed the path toward emergency use authorization for COVID-19 diagnostics. This step may reduce development costs, speed the process for availability at more testing sites, incentivize private development and, ultimately, help save lives,” Rick Bright, PhD, director of the Biomedical Advanced Research and Development Authority, said in an FDA press statement. “At BARDA, we are identifying industry partners to develop rapid diagnostics that can be used in commercial and hospital labs or even doctors’ offices so that medical professionals and their patients have the information they need to take action.”
Following the completion of their test validation, laboratories should communicate with the FDA, via email, to notify the agency that the test has been validated. Laboratories should submit a completed EUA request within 15 business days of notification.