International Medical Device Regulatory Monitor

Makers of in vitro diagnostics (IVD) for human papillomavirus (HPV) should request a pre-submission meeting with the U.S. Food and Drug Administration (FDA) if they plan to use data from clinical trials in other countries to support their premarket approval (PMA) application, a new draft guidance says. Includes the full text of US FDA Draft Guidance on In Vitro Diagnostic Devices.