Medical Device Development Tools (MDDT)

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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:

• 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.

• MDDT Categories
• How to Participate in the MDDT Program
• Qualified Tools

MDDT Categories

The FDA has defined three categories of MDDT:

• Clinical outcome assessment:measures of how a patient feels or functions. These could be patient-reported or clinician-reported rating scales like the NIH stroke scale, measures based on clinical decision-making, observer-reported outcomes such as from a parent or caregiver, or performance outcome measures, such as measures of gait speed or memory recall.
  • Examples of tools that might be eligible for qualification include: patient reported outcome rating scales, such as those used to measure pain, improved mobility, symptom relief, function, or health status and heart failure-related hospitalization.
• Biomarker test: a lab test or instrument used to detect or measure an indicator of biologic processes or pharmacologic responses to a treatment (biomarker).
  • Examples of tools that might be eligible for qualification include: tests used as an aid in diagnosis, for patient selection, or as clinical study endpoints, such as instruments or methods for measuring blood pressure; or instruments or methods for measuring certain concentrations of serum proteins, such as an assay to detect the level of a specific hormone in a patient in order to determine enrollment eligibility for study population in a clinical trial.
• Nonclinical assessment model: a nonclinical test method or model (e.g. in vitro “bench,” animal or computational model) that measures or predicts device function or performance in a living organism.
  • Examples of tools that might be eligible for qualification include: models used to measure a parameter of interest or to substitute for another generally accepted test or measurement, such as computer modeling to assess conditions typically evaluated through human, animal or bench testing to evaluate a device instead of collecting data from human subjects; use of tissue and other material phantoms to evaluate imaging devices; or In vitro models to replace animal testing.

More information about the categories of MDDT is in the final guidance.

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