This guidance describes a voluntary program for the qualification of medical device development tools (MDDTs) for use in the evaluation of devices regulated by CDRH.  Specifically, this guidance describes the framework for voluntary proposal and qualification of an MDDT, including definitions of applicable terms, criteria for evaluating an MDDT for a specific context of use, considerations for qualification, and the contents of a qualification package.

CDRH believes that MDDTs will facilitate the development and timely evaluation of medical devices by providing a more efficient and predictable means for collecting information to support regulatory submissions and associated decision-making



Qualification of Medical Device Development ToolsGuidance for Industry, Tool Developers, and Food and Drug Administration StaffJULY 2023