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The FDA’s Medical Device Development Tools (MDDT) program is a way for the FDA to qualify tools that medical device sponsors can use in the development and evaluation of medical devices.
Qualification means that the FDA has evaluated the tool and concurs with available supporting evidence that the tool produces scientifically-plausible measurements and works as intended within the specified context of use.
The context of use depends on:
More information about the context of use is in the final guidance on Medical Device Development Tools.
The MDDT program promotes innovation in medical device development and regulatory science to help bridge the gap between research of medical devices and the delivery of devices to patients.
The FDA has defined three categories of MDDT:
More information about the categories of MDDT is in the final guidance.