The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies.
Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.
Section 564 of the FD&C Act was amended by the Project Bioshield Act of 2004 and was further amended by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), the 21st Century Cures Act of 2016, and Public Law 115-92 of 2017.
Questions & Answers
- In March 2020, FDA posted FAQs on Diagnostic Testing for SARS-CoV-2.
- In January 2014, FDA issued a question and answer document (PDF, 762K) to respond to questions raised by public health stakeholders about PAHPRA’s amendments to the EUA authority and establishment of new authorities related to the emergency use of MCMs during CBRN emergencies.
Emergency Diagnostics Information
- Emergency Use Authorizations (current device EUAs)
- How to Submit a Pre-EUA for In vitro Diagnostics (IVDs) to FDA (for test manufacturers)
- Information for Laboratories Implementing IVD Tests Under EUA (Current EUAs)
The tables below provide information on current EUAs:
- Anthrax EUAs
- Coronavirus Disease 2019 (COVID-19) EUA Information
- Ebola Virus EUA Information
- Enterovirus D68 (EV-D68) EUA Information
- Freeze Dried Plasma Information
- H7N9 Influenza EUA Information
- Middle East Respiratory Syndrome Coronavirus (MERS-CoV) EUA Information
- Nerve Agent EUA Information
- Zika Virus EUA Information
Information about EUAs that are no longer in effect is available on our EUA archive page.
Source: U.S. Food & Drug Administration
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