FDA Updates Guidance on Human Papillomavirus IVD Device Studies

The FDA released final guidance for designing studies aimed at establishing performance characteristics of in vitro diagnostic devices for human papillomavirus.

Recommendations in the 41-page document on studies designed to support premarket applications for HPV IVDs replace the policy set forth in final guidance issued Nov. 28, 2011. The 2011 document did not include recommendations on the device description or test methodology information that should be included in PMAs.

The failure of devices may lead to incorrect patient management decisions in cervical cancer screening and treatment, the agency said.