Over the past month, in response to the COVID-19 pandemic, the US Food and Drug Administration (“FDA”) has invoked its statutory authority to issue a series of Emergency Use Authorizations (“EUAs”) that allow the distribution of certain products for use in the diagnosis, prevention, and treatment of COVID-19 that could not otherwise be distributed for those purposes. Manufacturers and distributors of such products should be aware of the (sporadically updated) EUAs and their limits.

In general, products that are intended to diagnose and treat disease may not be distributed in the United States absent FDA authorization. Although authorization to distribute drugs and medical devices may be obtained via various regulatory routes depending on the product in question, obtaining such authorization is usually a time-consuming endeavor, as the manufacturer must demonstrate the product’s safety and efficacy under the conditions stated in the product’s proposed labelling.

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