The Food and Drug Administration (FDA) has updated their policy on diagnostic testing for COVID-19 in order to achieve more rapid testing capacity in the U.S.
The FDA is initiating a policy for states to take responsibility for tests developed and used by laboratories in their states. States can set up a system in which they take responsibility for authorizing such tests, and the laboratories will not engage with the FDA. Under the updated policy, the FDA does not intend to object to commercial manufacturers distributing and labs using new commercially developed tests prior to the FDA granting an emergency use authorization (EUA), under certain circumstances. The FDA is aware that numerous commercial manufacturers are developing tests for coronavirus with the intention of submitting an EUA to the FDA. During this public health emergency, the FDA does not intend to object to the distribution and use of these tests for specimen testing for a reasonable period of time after the manufacturer’s validation of the test and while the manufacturer is preparing its EUA request.
In addition, the updated policy provides recommendations for test developers who may wish to develop serological tests for use during this coronavirus outbreak. Serological tests measure the amount of antibodies or proteins present in the blood when the body is responding to a specific infection. The FDA does not intend to object to the distribution and use of serology tests to identify antibodies to SARS-CoV-2 where the test has been validated, notification is provided to the FDA, and warning statements are included with the tests noting the test has not been reviewed by the FDA and results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
Food and Drug Administration (FDA). Coronavirus (COVID-19) Update: FDA Provides More Regulatory Relief During Outbreak, Continues to Help Expedite Availability of Diagnostics [press announcement]. March 16, 2020. Available at: click here. Accessed March 17, 2020.