FDA gives advice on rules for new bird flu tests

Apr 13, 2006 (CIDRAP News) – The Food and Drug Administration (FDA) issued a regulatory guidance document this week to help spur the development of diagnostic tests for avian influenza in humans.

The document, issued Apr 10, is intended to help medical technology companies meet FDA requirements when developing new tests for influenza A viruses, the FDA said in a Federal Register notice.

The agency said the move was prompted by the public health concern over the human cases of H5N1 avian flu and the associated threat of a human flu pandemic. "FDA is making this guidance document immediately available because prior public participation is not feasible given the national and global public health threat of pandemic influenza," the notice says.

The document gives information on labeling requirements and outlines the "premarket regulatory path" for new tests to detect either influenza A viruses in general or specific influenza A virus subtypes.

Flu tests already approved by the FDA are designed to detect influenza A in general—not specific subtypes—and were developed when only H3 and H1 viruses were circulating, the FDA said. There is no evidence that the existing tests "would reliably detect novel influenza A viruses" from human samples, the notice said.

The guidance is effective immediately, but the FDA is accepting comments on it (see links below for information on submitting comments). The agency did not list a deadline for commenting.

See also:

FDA Federal Register notice on flu tests
http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-5203.htm

FDA guidance document "In Vitro Diagnostic Devices to Detect Influenza A Viruses: Labeling and Regulatory Path"
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm078538.htm