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.

Product Showcase

  • Matrix's OmniPro Vision AI Collision Avoidance System

    OmniPro Vision AI is a state-of-the-art collision avoidance system that features NIOSH award-winning Visual Artificial Intelligence (AI) technology. This highly accurate, powerful system identifies and alerts on pedestrians, vehicles and specified objects, ensuring safer facilities, mining operations and industrial sites. With its web-based cloud application, OmniPro Vision AI also logs and analyzes a wide range of data related to zone breach notifications. Operating without needing personal wearable devices or tags, OmniPro has visual and audible zone breach alerts for both operators and pedestrians. Read More

  • EMSL Analytical, Inc. - Air Sampling Supplies & Testing Labs

    EMSL Analytical, Inc. operates laboratories throughout the United States and Canada. EMSL is a nationally recognized and locally focused provider specializing in fast laboratory results for Asbestos, Mold, Silica, Lead & Metals, Bacteria, Legionella, USP , Combustion By-Products, VOC’s, Radon, PCB’s, Formaldehyde, METH/Fentanyl, Identification of Dust & Unknowns. Sampling Pumps, Cassettes, Media & Supplies available. Reach us at 1-800.220.3675 Read More

  • SwabTek® Cannabis Test Kit

    The SwabTek® Cannabis Test Kit is a single-use spot test designed for use in screening for cannabis compounds in any sample type or on any surface. The test is capable of identifying the presumed presence of cannabinoids in very small quantities, with a level of detection as little as 6 μg in mass. Learn more about the SwabTek® Cannabis Test Kit and the rest of SwabTek surface drug testing solutions through the webinar titled "Everything You Want To Know About Surface Testing" Read More

Featured

Webinars