US FDA Issues Revised Guidance on Qualification of Medical Device Development Tools

This final guidance supersedes Qualification of Medical Device Development Tools: Guidance for Industry, Tool Developers, and Food and Drug Administration Staff issued on August 10, 2017. It describes a voluntary program for the qualification of medical device development tools (MDDTs) for use in the evaluation of devices regulated by CDRH.

 

In addition to definition of key concepts, and an overview of the MDDT qualification program, the guidance provides information on the CDRH qualification decision framework and the public communication of the qualification decision.