FDA Issues Guidance on In Vitro Devices to Detect Human Papillomaviruses

The FDA has released a draft guidance to establish performance characteristics of in vitro devices for the detection or detection and differentiation of human papillomaviruses.

These devices can be used in conjunction with cervical cytology to aid in screening for cervical cancer or as a first-line primary cervical cancer screening device.

When finalized, the guidance is expected to provide detailed information about the types of studies recommended to support a premarket application for these devices.

Interested parties can comment on the draft through Nov. 12. Read the guidance, Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection and Differentiation of Human Papillomaviruses, at www.fdanews.com/08-14-15-papillomaviruses.pdf. — John Bechtel