H1N1 Flu

Emergency Use Authorization (EUA) of Medical Products and Devices

What is EUA?

What are the products currently under EUA?

CDC-requested and FDA-issued EUA Products:

Tamiflu (oseltamivir)
Relenza (zanamivir)
N95 Respirators May 4
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 May 2

Reasons for Relenza EUA May 2

Reasons for rRT-PCR Swine Flu Panel EUA

FDA Related Information

FDA News Release Apr 27

EUA Guidance Document

FDA 2009 H1N1 Virus site

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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