The Human-Device Interaction Program in the FDA’s Center for Devices and Radiological Health (CDRH) conducts regulatory science research to help ensure patient access to diagnostic, therapeutic, and assistive medical devices that are safe and effective. This is one of 20 research program areas in CDRH’s Office of Science and Engineering Laboratories (OSEL).
There has been a surge of novel diagnostic, therapeutic, and assistive medical devices that play an important role in identifying or monitoring a clinical condition and restoring or maintaining quality of life and function for individuals impacted by a medical condition. Examples include:
- Advanced limb prosthesis technology that provides more natural, intuitive control of complex hand/leg movements, improves functionality, and improves prosthesis “embodiment” (the process that leads to something becoming part of the body-image).
- Wearable technologies that capture and analyze movement patterns for diagnostic or therapeutic purposes.
- Virtual reality (VR)-based therapies that offer a dynamic and engaging rehabilitation environment and have provided relief to patients during painful movements and procedures.
The FDA regularly receives submissions presenting these technologies and anticipates further in the robotic, wearable, and virtual/augmented reality device spaces. However, despite the increased use of these emerging technologies in medical devices, methods that (1) evaluate their clinical effectiveness and benefit and (2) streamline the development and regulatory review of new devices are still lacking.
Regulatory Science Gaps and Challenges
Major regulatory science gaps and challenges that drive the Human-Device Interaction Program are:
- Incorporating wearable technologies’ new endpoints and measurements into medical devices requires study of their accuracy and repeatability under various conditions, as well as an understanding of the normative distribution of novel metrics.
- Lack of objective criteria to compare new interfaces for assistive devices, such as brain/nerve interfacing devices, to existing prostheses and functional intact limbs and make informed benefit-risk determinations.
- Questions related to the efficacy of novel VR-based treatment approaches in various clinical populations remain (for example, mechanism of action, impact of immersion and VR environment, and recommended dosage).
The Human-Device Interaction Program is uniquely positioned to identify and address these regulatory hurdles through the development of test methods and publicly available datasets that can be used to streamline the regulatory review of user interfaces and technologies for diagnostic, therapeutic, and assistive medical devices.
Human-Device Interaction Program Activities
The Human-Device Interaction Program focuses on regulatory science research in these areas:
- Scientific evaluation of the sources of variability in smartphone- and smartwatch- based wearable sensors.
- Developing methodology to validate 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.
- Systematic comparison of motion analysis systems for quantitative assessment of upper limb function.
- Evaluating the efficacy of novel VR-based treatments for pain and demonstrate a multimodal approach to measuring pain.
For more information, email OSEL_humandeviceinteractions@fda.hhs.gov