The US Food and Drug Administration (FDA) has issued a new policy designed to help laboratories developing diagnostic tests for coronavirus to speed their progress. It allows laboratories to immediately use tests they developed and validated; the goal is to achieve more rapid testing capacity nationwide.
The guidance, downloadable from the FDA website, includes various recommendations and information for developers, such as details on test validation, FDA notification and interim confirmatory clinical testing. Once a laboratory has completed test validation, they are instructed to notify the FDA via email.
FDA commissioner Stephen Hahn said the measure “strikes the right balance” between accelerating development and protecting public health.
“This action today reflects our public health commitment to addressing critical public health needs and rapidly responding and adapting to this dynamic and evolving situation,” he said.
The new policy impacts laboratories that started to develop and began to use validated coronavirus diagnostics prior to the FDA completing use of emergency use authorization (EUA) requests.
The FDA holds the power to issue an EUA to allow the use of specific medical products that could be effective in diagnosing, treating or preventing a disease or condition, based on scientific data. An EUA can be approved in the event the Secretary of Health and Human Services (HHS) deems there is an existing or potential public health emergency or a significant potential for a public health emergency.
FDA public affairs representative Stephanie Caccomo told Outsourcing-Pharma that to date, the HHS has issued two EUAs determination regarding coronavirus. A total of four laboratories have reached out to inquire after the newly issued policy.
Following the completion of their test validation, laboratories should communicate with the FDA, via email, in order to notify the agency that the test has been validated.