Emergency Use Authorization (EUA) of Medical Products and Devices
Please be advised that all of the CDC-sponsored EUAs listed on this website are currently in effect and will remain in effect through June 23, 2010, unless the declaration of emergency is terminated or the Emergency Use Authorizations are revoked sooner or the declaration of emergency is extended. Additional information and guidance regarding EUA termination will be posted on this website closer to the eventual termination date.
What is EUA?
What are the products currently under EUA?
CDC-requested and FDA-issued EUA Products:
Antiviral Drugs:
- Tamiflu (oseltamivir)
- Relenza (zanamivir)
- Peramivir IV
Devices:
- N95 Respirators
- rRT-PCR Flu Panel (NPS, NS, TS, NPS/TS, NA)
- rRT-PCR Swine Flu Panel (also referred to as Swine Flu Test Kit)
For other medical products also currently FDA-authorized for use under EUAs (requested by non-CDC entities) in response to novel H1N1 flu (swine flu), please visit the FDA 2009 H1N1 Virus site and scroll down to the section entitled FDA Regulated Products.
Why is EUA necessary?
FDA Related Information
For questions regarding EUAs, contact: EUA.OCET@fda.hhs.gov
EUA Online Course
An EUA online course developed by the Food and Drug Administration and Centers for Disease Control and Prevention to provide public health officials, emergency managers, or SNS coordinators with an introduction to the Emergency Use Authorization of medical products.
Note: Continuing Education Units (CEUs) are not offered for the EUA course.
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