Cervical Cancer

HiFi DNA Tech Tells FDA It is ''Unreasonable'' and Should Study the Science of HPV DNA PCR and DNA Sequencing for Genotyping

Published in Medical Device Law Weekly, May 4th, 2008

HiFi DNA Tech of Trumbull, CT told a federal judge the Food and Drug Administration (FDA) "has not kept pace with the advances in molecular biology for the past 20 years, which unfortunately does not benefit women who may have HPV." The Memorandum in Opposition was filed in U.S. District Court in Bridgeport, CT, April 11 in connection with a lawsuit for reclassification of a HPV genotyping device.

The FDA has been unreasonable in demanding the plaintiff to demonstrate human papillomavirus (HPV) genotyping can be used to diagnose cervical cancer in reviewing a petition to reclassify an HPV DNA PCR (polymerase chain reaction) device from a class III test to a class II...

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Source: Medical Device Law Weekly (2008-05-04)

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