U.S. flag An official website of the United States government

Regulatory Science Tools Catalog

The Regulatory Science Tools Catalog provides a peer-reviewed resource for use where standards and qualified Medical Device Development Tools (MDDTs) do not yet exist. These tools do not replace FDA-recognized standards or MDDTs. This catalog collates a variety of regulatory science tools that the FDA's Center for Devices and Radiological Health's (CDRH) Office of Science and Engineering Labs (OSEL) developed. If you are considering using a tool from this catalog in your marketing submissions, note that these tools have not been qualified as Medical Device Development Tools and the FDA has not evaluated the suitability of these tools within any specific context of use. You may request feedback or meetings for medical device submissions as part of the Q-Submission Program.


HDI
This regulatory science tool is an open-access dataset containing raw inertial measurement unit (IMU) and sensorized insole data from individuals with Parkinson’s Disease (PD) and age-matched controls synchronized to a gait walkway reference system that can serve as a tool to assess novel algorithms deriving gait metrics through wearables and explore measurable connections between gait, PD severity, PD progression, and controls, thus leading to future clinical enhancements and treatments for patients.
HDI
This regulatory science tool presents an open-access dataset tool for the assessment of wearable technology deriving gait parameters.
HDI
A performance-based method requiring controlled grasping, transport, and release of objects that can be used to evaluate upper limb functional ability.