This document provides guidance on a voluntary program for qualification of medical device development tools (MDDT) for use in evaluating devices subject to regulation by Center for Devices and Radiological Health (CDRH). CDRH believes that this policy will facilitate the development and timely evaluation of medical devices, by providing a more efficient and predictable means for collecting the necessary information to support regulatory submissions and associated decision-making.
The purpose of this guidance is to describe the framework and process 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. For purposes of this guidance, a submitter is a person, group, consortium, or organization (including the federal government) that takes responsibility for and initiates the MDDT qualification process using the procedures described in this guidance.
This guidance does not discuss the review of tools that are submitted in individual premarket regulatory submissions for use with a particular medical device nor does it address the specific evidentiary or performance expectations for the qualification of an individual MDDT submission.