Typically, FDA approval takes many years of testing and clinical trials. During a public health emergency (like the COVID-19 pandemic, the FDA can use its Emergency Use Authorization (EUA) authority to allow the use of unapproved medical products, or unapproved uses of approved medical products, to diagnose, treat, or prevent serious or life-threatening diseases when certain criteria are met, including that there are no adequate, approved, and available alternatives.
The "EmpowerDX COVID-19 Home Collection Kit DTC" laboratory analysis is performed by (1) Clinical Enterprise, Inc. (EUA summary here) and by (2) Viracor Eurofins Clinical Diagnostics (EUA summary here) using the "Viracor SARS-CoV-2 Assay DTC" as a direct to consumer product for testing of anterior nasal swab specimens collected by empowerDX customers.
This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA for use by authorized laboratories (1) and (2) listed above.
This product has been authorized only for the detection of nucleic acid from SARS- CoV-2, not for any other viruses or pathogens.
This product is not a pooled test or a screening test. Each test kit includes contents for one person to use the nasal swab, ship the completed test kit to lab (1) or lab (2) for analysis, and get HIPAA-compliant results in a secure online portal.
The emergency use of this product is only 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 Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.