A guidance has been posted titled, “Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses - Draft Guidance for Industry and Food and Drug Administration Staff.”
FDA is issuing this draft guidance to facilitate study designs to establish the performance 101 characteristics of in vitro diagnostic devices (IVDs) intended for the detection, or detection and 102 differentiation, of human papillomaviruses (HPVs). These devices are used in conjunction with 103 cervical cytology to aid in screening for cervical cancer or as first-line primary cervical cancer 104 screening devices. These devices include those that detect a group of HPV genotypes, 105 particularly high risk HPVs, as well as devices that detect more than one genotype of HPV and 106 further differentiate among them to indicate which genotype of HPV is present. More than 100 107 HPV genotypes have been identified, approximately 40 of which can infect the genital tract [Ref. 108 1]. Infection with ‘high-risk’ types of HPV is considered a necessary cause of virtually all 109 cervical cancer [Ref. 2]. Approximately fourteen HPV genotypes are considered carcinogenic or 110 “high risk” [Ref. 3 & Ref. 20]. For the remainder of this document, “HPV” refers to a “high 111 risk” HPV, except where otherwise noted. A “high risk HPV test” refers to an HPV IVD device 112 that detects, but does not differentiate between different types of HPV; while a “HPV genotyping 113 test” refers to an HPV IVD device that detects and further differentiates HPV types (some HPV 114 tests provide individual HPV genotyping results in addition to the results of pooled probes).
To view the Guidance, please see:
MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/UCM458179. pdf.