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.

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’ 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