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 product area, the stage of medical device development, and the role of the tool in device evaluation. More information about the context of use is in the draft guidance on Medical Device Development Tools.
The 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 Pilot Program
The goal of the voluntary MDDT pilot program is to assess and refine the qualification process for tools used to develop and evaluate medical devices. The program aims to provide MDDT developers and medical device manufacturers with a mechanism for discussing early concepts about a tool, fostering collaboration on tool development and potentially increasing adoption and use of the qualified tools.
How to Participate in the Pilot Program
There are no fees associated with submitting a tool for qualification. Any tool developer, medical device manufacturer, or others involved in medical device development such as research organizations and academia can voluntarily submit a proposal for their tool to MDDT@fda.hhs.gov. FDA intends to limit the MDDT Pilot Program to no more than 15 candidates. For information about how to submit a proposal, please go to Procedures section of the Federal Register Notice.
The FDA has defined three categories of MDDT:
- Clinical outcome assessment: subjective measures of how a patient feels or functions, such as patient-reported or clinician-reported rating scales like the NIH stroke scale, or measures based on clinical decision-making.
- 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, medical imaging method, or other objective clinical assessment method 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.
- Nonclinical assessment model: a nonclinical test method or model (e.g. in vitro “bench,” animal or computational model) that simulates 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 draft guidance.
The FDA will keep proprietary information confidential, and places no requirements on licensing, pricing, or intellectual property.
The FDA plans to make public any decisions to qualify a MDDT, the tool’s context of use, and a summary of evidence and basis for FDA’s qualification decision. This does not include proprietary information or intellectual property. Prior to participating in the pilot, the tool submitter can discuss with the FDA the level of information that they deem appropriate for public disclosure.
The tool developer determines the conditions of use of a tool such as licensing, cost, or degree of access to Intellectual Property associated with the tool. However, qualified tools must be accessible to the public, and not restricted to certain private entities, such as a single manufacturer.
More information about the qualification process is in the MDDT Pilot Program Federal Register Notice.