FAQs - FDA EUA and Literature Update > What is an Emergency Use Authorization (EUA)?

What is an Emergency Use Authorization (EUA)?

posted on 1:30 PM, July 9, 2020

The U.S. Food and Drug Administration has the regulatory authority under the Federal Food, Drug, and Cosmetic Act (as amended) [Title 21 (Chapter 9) of the United States Code] to issue EUAs during public health emergencies to strengthen U.S. public health protections. Either unapproved medical products or unapproved uses of approved medical products (devices or drugs) can be allowed. Examples of unapproved medical products would be new tests or platforms to identify SARS-CoV-2 current or past infection. Examples of unapproved uses of approved medical products would be medications used for treating COVID-19 based on early data or extrapolations of other data in the absence of formal processing of a new drug indication application (commonly known as “off-label” use). While off-label use of a medication can occur based on accumulating medical knowledge, the existence of an EUA for a drug allows such actions as distributing medical countermeasures from the Strategic National Stockpile where applicable, and provides some liability protection for prescribing medication in a public health emergency. Prescribers are still required to report serious adverse events from medication use under an EUA through the FDA’s MedWatch Program. The FDA provides recommended guidance to manufacturers and laboratories to conduct validation for proposed tests; consumers and health professionals are encouraged to report concerns about problematic devices or fraudulent practices. Please see the FDA’s Emergency Use Authorization page for more information.