FDA publishes guidance on developing diagnostic tests for 2009 H1N1
3 November 2009
The US Food and Drug Administration (FDA) has published a
guidance document for helping 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
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.
guidance outlines information the FDA recommends be included, and the
FDA gives these requests thorough and careful review to protect the
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
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.
For more information:
The FDA's Guidance Document on 2009 H1N1 Influenza Virus Diagnostics:
The FDA's Emergency Use Authorization of Medical Products
The FDA's Emergency Use Authorization Questions and Answers