Update to FDA guidance on qualification of medical device development tools
“Qualification of Medical Device Development Tools: Guidance for Industry, Tool Developers, and FDA Staff,” was issued in July 2023. This document, an update of guidance issued is 2017, provides guidance on a voluntary program for qualification of medical device development tools for use in evaluating devices subject to regulation by FDA’s Center for Devices and Radiological Health. Medical device development tools are methods, materials, or measurements used to assess the safety, effectiveness, or performance of medical devices. They can include new approach methodologies, biomarker tests, and clinical outcome assessments.