FDA has published a draft guidance titled Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses. It contains recommendations for studies to establish the analytical and clinical performance of in vitro diagnostic devices intended for detection or detection and differentiation of human papillomaviruses (HPV).
The guidance says that the devices are used in conjunction with cervical cytology to aid in screening for cervical cancer. They include devices that detect a group of HPV genotypes, particularly high-risk viruses, and devices that detect more than one genotype of HPV and further differentiate among them to indicate which HPV genotypes are present.
FDA says that the guidance provides detailed information on the types of studies that the agency recommends to support premarket approval for these devices. It is limited to studies intended to establish the devices’ performance characteristics and does not address HPV devices that are intended to be used independent of a cervical cytology result. It specifically addresses devices that qualitatively detect HPV nucleic acid from cervical specimens, although many of the recommendations are also applicable to devices that detect HPV proteins. The guidance may be accessed at www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm181509.htm.
—James G. Dickinson [Washington Wrap-Up, November]
