Emergency Use Authorization
What does Emergency Use Authorization (“EUA”) mean?
Medical devices, medicines, and other products under the purview of the Federal Drug Administration (“FDA”) must comply with a standard set of guidelines that are set by the FDA. For any given product, all of the products in this category were tested in the same manner, passed the same experiments, and met the same levels of safety and efficacy. Depending on the type of product and the specific tests required, it can take several years to achieve approval.
The FDA has systems in place to meet public need in times of crisis to enable a faster response. On February 4, 2020, The Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency involving the virus SARS-CoV-2. At this time the FDA set some guidelines for EUA for a variety of tests, therapies, and potential treatments. These guidelines have been updated several times since the initial declaration, so that the FDA can adjust as needed to the pandemic.
This COVID-19 RT-qPCR Test has met the EUA requirements. Wheeler Labs has met and must continue to meet strict requirements set by the FDA to perform this test. This test will only be authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
For more information about general EUA, the FDA’s COVID response, or general FDA guidelines, the following resources are available.
https://www.fda.gov/industry/fda-basics-industry/guidances