2nd Circ. Won't Force HPV Test Reclassification

Law360, New York (December 18, 2009, 4:17 PM EST) -- DNA test reagent manufacturer HiFi DNA Tech LLC has lost its appeal to compel the U.S. Food and Drug Administration to reclassify devices for detecting human papillomavirus, or HPV, as virology testing devices instead of as cervical cancer tests.

The U.S. Court of Appeals for the Second Circuit on Thursday affirmed the judgment of the U.S. District Court for the District of Connecticut, ruling that the lower court had not acted arbitrarily or capriciously.

HiFi has developed a molecular virology test device to detect HPV. It...
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