The Human-Device Interaction Program within FDA’s Center for Devices and Radiological Health (CDRH), conducts research to help patients have access to diagnostic, therapeutic and assistive medical devices that are safe and effective.
The Human Device Interaction Program focuses on regulatory science in these areas:
- Evaluating variability in smartphone and smartwatch-based wearable sensors
- Validating wearable sensors for gait
- Establishing normative distributions for movement metrics derived from wearables
- Developing a mental workload assessment model for clinical populations with upper limb impairment
- Doing a systematic comparison of motion analysis systems for quantitative assessment of upper limb function
- Evaluating the efficacy of novel VR-based treatments for pain to demonstrate a multimodal approach to measuring pain.
FDA receives submissions presenting technologies and anticipates further submissions in the robotic, wearable, and virtual/augmented reality device spaces. However, methods that evaluate clinical effectiveness, benefits, and streamlines the development and regulatory review of new devices is still lacking.
Go to https://fda.gov/about-fda/fda-organization/center-devices-and-radiological-health for more information.