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GUIDANCE DOCUMENT

Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses Guidance for Industry and Food and Drug Administration Staff September 2017

Download the Final Guidance Document
Final
Docket Number:
FDA-2009-D-0386
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

FDA is issuing this guidance to facilitate study designs to establish the performance characteristics of in vitro diagnostic devices (IVDs) intended for the detection, or detection and differentiation, of human papillomaviruses (HPVs). These devices are used in conjunction with cervical cytology to aid in screening for cervical cancer or as first-line primary cervical cancer screening devices. These devices include those that detect a group of HPV genotypes, particularly high risk HPVs, as well as devices that detect more than one genotype of HPV and further differentiate among them to indicate which genotype of HPV is present. Approximately 200 HPV genotypes have been identified, about 40 of which can infect the genital tract [Ref. 1]. Infection with ‘high-risk’ types of HPV is considered a necessary cause of virtually all cervical cancer [Ref. 2]. Approximately fourteen HPV genotypes are considered carcinogenic or “high risk” [Ref. 3 & Ref. 20]. For the remainder of this document, “HPV” refers to a “high risk” HPV, except where otherwise noted. A “high risk HPV test” refers to an HPV IVD device that detects, but does not differentiate between different types of HPV; while a “HPV genotyping test” refers to an HPV IVD device that detects and further differentiates HPV types (some HPV tests provide individual HPV genotyping results in addition to the results of pooled probes).

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All written comments should be identified with this document's docket number: FDA-2009-D-0386.

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