FDA releases draft guidance on dual IVD submissions

FDA released draft guidance for study designs for new in vitro diagnostic (IVD) devices that can support both a 510(k) clearance and CLIA waiver application.

To streamline regulatory approval for certain Class I and II IVD devices, FDA established a dual pathway during the 2012 Medical Device Use Fee (MDUFA) reauthorization to allow 510(k) and CLIA waiver applications to be reviewed under a single submission, reducing the overall review time. FDA said dual submissions are appropriate for devices that are simple, have fail-safe and failure alert mechanisms, have few pre-analytical steps, and are subject to premarket notification requirements. ...