FDA Releases Draft Guidance for HPV IVD Tests | GenomeWeb

NEW YORK (GenomeWeb News) – The US Food and Drug Administration today issued a draft guidance for industry and FDA staff covering how in vitro diagnostic devices for human papillomaviruses should be measured and handled for analytical and clinical performance.

FDA's Center for Devices and Radiological Health released the guidance today for comment purposes, providing a set of recommendations for the types of studies of IVDs that are intended to detect and differentiate HPV strains and are used in conjunction with cervical cancer screening.

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