FDA Publishes Guidance on Diagnostic Tests for 2009 H1N1 Influenza Virus

SILVER SPRING, Md., Nov. 2 /PRNewswire-USNewswire/ -- The U.S. Food and Drug
Administration today published a guidance document that should help
manufacturers develop diagnostic tests for the 2009 H1N1 influenza virus.
Although there are not any FDA-approved or cleared tests that diagnose this
specific infection, during this pandemic manufacturers can submit a request to
the FDA for an Emergency Use Authorization (EUA). If granted, the EUA will
allow the test to be used during the national public health emergency declared
by Department of Health and Human Services Secretary Kathleen Sebelius in
April. This guidance document outlines what information the FDA recommends
that manufacturers include in these EUA requests.

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The EUA authority allows the FDA to authorize use of unapproved or uncleared
medical products or unapproved or uncleared uses of approved or cleared
medical products following a declaration of emergency, when certain criteria
are met. The authorization ends when the declaration of emergency is
terminated or the authorization is revoked by the FDA.

The EUA authority is part of Project BioShield, which became law in July 2004.

While the FDA encourages manufacturers to submit appropriate premarket
applications for these tests, the agency also recognizes that it may not be
possible to generate complete clinical validation data that would normally be
included in an application. However, this guidance outlines information the
FDA recommends be included, and the FDA gives these requests thorough and
careful review to protect the public health.

During this declared public health emergency, manufacturers of 2009 H1N1
influenza virus tests that are unable to submit a complete premarket
notification may use the guidance to submit a request for an EUA.

The guidance document is part of the FDA's ongoing efforts to provide public
health authorities managing the pandemic with reliable and accessible
diagnostic tests. The guidance is available online at
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM188679.pdf,
and will remain in effect throughout the public health emergency.

For more information:

The FDA's Guidance Document on 2009 H1N1 Influenza Virus Diagnostics
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM188679.pdf
The FDA's Emergency Use Authorization of Medical Products
http://www.fda.gov/RegulatoryInformation/Guidances/ucm125127.htm
The FDA's Emergency Use Authorization Questions and Answers
http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm153297.htm

Media Inquiries: Peper Long, 301-796-4671; mary.long@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration

Peper Long of the U.S. Food and Drug Administration, +1-301-796-4671,
mary.long@fda.hhs.gov