Our FDA team published a LawFlash on the Food and Drug Administration’s (FDA’s) recent Emergency Use Authorizations (EUAs) for the first over-the-counter (OTC) COVID-19 test to be performed at home and the first OTC home sample collection kit for COVID-19 testing, as well as additional prescription at-home tests and sample collection kits. These newly authorized testing options are expected to help address the critical public health need for additional COVID-19 test capacity. FDA’s authorization of these new EUAs also makes good on promises the FDA made to prioritize its review of rapid and at-home test solutions.
These new EUAs are significant for test developers looking to enter the COVID-19 test space and eyeing a quick FDA authorization process because they provide useful insights regarding the FDA’s review priorities and expectations with respect to data and test performance.