Business · 26/02/2020

FDA Releases Guidance on Dual 510(k) and CLIA Waiver by Application Studies

The Food and Drug Administration (FDA) has released a final guidance document outlining a pathway for manufacturers to obtain both 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver for new in vitro diagnostic (IVD) tests through a single application process. This optional pathway is believed to be the least burdensome and fastest approach for manufacturers to bring simple and accurate IVD tests to CLIA-waived settings, ultimately benefiting patients and providers.