On March 16, 2020, FDA finalized its guidance titled Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (the “Policy”). The Policy includes information and recommendations to assist laboratories and commercial manufacturers in development of diagnostic tests for the novel coronavirus (“COVID-19”) during the ongoing pandemic.
During the first week of implementation, questions arose regarding the extent to which the Emergency Use Authorization (“EUA”) pathway to market, as described by the Policy, covers at-home tests. The Policy specifically provides that it “does not apply to at home testing” (emphasis added). However, the industry still questioned the FDA’s stance on the use of at-home collection kits, allowing a consumer to self-collect a specimen and mail in a swab or similar collection device to a laboratory running an FDA-approved COVID-19 test.
On Saturday, March 21, 2020, FDA updated its Frequently Asked Questions page to address this discrepancy. The Agency first confirmed that it has not authorized any tests for consumers to purchase and test themselves at home for COVID-19, but states that it is “actively working with test developers in this space.” In addition, FDA clarifies that its statement in the Policy that the guidance therein is not applicable to at-home testing includes self-collection of samples to be sent to a clinical laboratory. FDA further encourages test developers to discuss validation of such products early in the development process. Thus, while self-swabbing in the presence of a medical professional may be permitted, FDA currently does not authorize at-home self-collection of specimen for COVID-19 testing.
To assist laboratories and manufacturers to answer questions regarding development of diagnostic tests for COVID-19, FDA offers a toll-free Coronavirus COVID-19 Diagnostic Tests Hotline that is open 24-hours a day (1-800-INFO-FDA, choosing option *). Developers can also contact their attorney at Epstein Becker & Green with questions regarding these updates.