Emergency Use Authorization (EUA) of Medical Products and Devices

What is EUA?

Questions & Answers

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?

Reasons for Tamiflu EUA

Reasons for Relenza EUA

FDA Related Information

FDA News Release

EUA Guidance Document

FDA 2009 H1N1 Virus site

FDA Information for Healthcare Professionals - Authorization of Use of Expired Tamiflu for Oral Suspension

Updated Questions and Answers: 2009 H1N1 Flu Virus and Emergency Use Authorization of Tamiflu and Relenza

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.