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Through use of an expedited review process, the U.S. Food and Drug Administration was able to complete the review and approve the Centers for Disease Control and Prevention's new test to detect avian influenza within two weeks of the time CDC submitted its application--an extraordinarily short timeline.
The FDA has administrative processes in place to ensure that new medical devices, including new laboratory tests, with profound public health importance can be prioritized and put on an accelerated approval schedule. FDA's expedited review process is designed to ensure that new devices that have important public health benefits are available for use as quickly as possible.
The CDC's test, officially called the Influenza A/H5 (Asian lineage) Virus Real-time RT-PCR Primer and Probe Set, consists of new laboratory reagents that will help identify a specific influenza virus that has been associated with cases of avian influenza in people from Asia and most recently Turkey.
The elements that made this expedited review possible were preliminary communications and intense coordination between FDA and CDC staff. These included up-front protocol discussions between FDA and CDC that took place in November 2005 as well as FDA's ability to review information in real time and obtain real time responses to questions from the CDC scientists responsible for the development of the test.
The CDC influenza test had no precedent device but could be processed as a 510(k) because of a new regulatory process provided by Congress in the 1997 Food Drug and Modernization Act that allows FDA to establish safety and effectiveness of certain devices using less burdensome regulatory procedures.
The CDC submitted its 510(k) application to the FDA electronically on January 18, 2006 and in hard copy of January 20, 2006 and through the diligence and hard work from both agencies, the test has been approved for use within two weeks.
This review process highlights the flexible regulatory tools FDA currently has that can be applied to new devices for a wide variety of uses to ensure rapid transfer of new technology from the research bench to clinical use.
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FDA Approves Test to Detect Human Infection with 'H5' Avian Flu Viruses (HHS Release, Feb. 3, 2006)