Industry to FDA: Guidance on HPV IVDs Needs Work

Diagnostics companies want more clarity and fewer sample requirements in the FDA’s final guidance on clinical studies of in vitro diagnostics (IVDs) for human papillomavirus (HPV). The FDA needs to provide more guidance on how to evaluate the ability of an IVD to detect the targeted HPV genotypes in a clinical data set, AdvaMed says in one of three comments submitted on the draft guidance.
Devices & Diagnostics Letter