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 fda/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 Diagnosticsfda/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM188679.pdf The FDA' Emergency Use Authorization of Medical Productsfda/RegulatoryInformation/Guidances/ucm125127.htmThe FDA's Emergency Use Authorization Questions and Answersfda/NewsEvents/PublicHealthFocus/ucm153297.htm