Guidance Published on Diagnostic Tests for 2009 H1N1 Influenza

The Food and Drug Administration recently 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 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 FDA recommends that manufacturers include in these EUA requests.

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

While FDA encourages manufacturers to submit appropriate premarket applications for these tests, the agency said it 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 agency recommends be included as it gives these requests a 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 is available online here, and will remain in effect throughout the public health emergency.

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