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:
- the tool or product area in which the tool is proposed for qualification
- the specific output or measure from the MDDT
- the role of the MDDT (for example, for clinical uses, including the study population or disease characteristics, as well as specific use-diagnosis, patient selection, and study endpoints), and
- the phases of medical device development during which the MDDT or tool measurements can be used (for example, design evaluation or early clinical study).
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.
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