The Medical Extended Reality Program in the FDA’s Center for Devices and Radiological Health (CDRH) conducts regulatory science research to help ensure patient access to innovative extended reality-based devices that are safe and effective. This is one of 20 research programs in CDRH’s Office of Science and Engineering Laboratories (OSEL).
Medical Extended Reality and Medical Devices
Advances in computing and displays have enabled a recent surge in low-cost, mixed-reality devices, including augmented reality (AR) and virtual reality (VR). These new capabilities have resulted in substantial interest in the development of medical extended reality (MXR) devices. Clinical researchers and medical device developers have begun to leverage this nascent technology for critical surgery, diagnostics, and therapeutics. However, because of the pace of development, the evaluation of MXR devices has significantly lagged, causing inefficiency and increased regulatory burden in ensuring the safety and effectiveness of MXR applications and in identifying acceptable claims.
Regulatory Science Gaps and Challenges
Major regulatory science gaps and challenges that drive the Medical Extended Reality Program are:
- A wide variety of MXR platforms that lack characterization and evaluation methods for different important medical applications such as interventional procedures and surgery or rehabilitation.
- Consumer-grade sensors, such as accelerometers, inertial measurement units, and cameras used by MXR platforms, that have not been validated for the clinical contexts of use.
- Few or no assessment tools for usability of the device, such as cognitive load which affect device safety and effectiveness in surgical and diagnostic applications.
The Medical Extended Reality Program is intended to fill these knowledge gaps by addressing open research questions related to the design, development, and evaluation of novel MXR devices and related applications. The outcomes of this program will provide the scientific foundation in support of regulatory requirements and decisions on innovative MXR devices.
Medical Extended Reality Program Activities
The Medical Extended Reality Program focuses on regulatory science research in these areas:
- Image quality characterization of MXR devices.
- MXR sensor characterization.
- Interventional procedures and surgical applications of MXR.
- Quantitative measurements for usability, such as cognitive load and cybersickness.
- Methods and tools to characterize the display hardware and consumer-grade HMD platforms used in MXR.
- Data that assists in identifying acceptable claims and validated technical capabilities for MXR.
- Metrics are necessary for evaluating the safety and effectiveness of emerging MXR devices.
- Strategies to mitigate or avoid the effects of cybersickness on users.
For more information, email OSEL_ARVR@fda.hhs.gov