April 15, 2020

ACR Submits Comments on FDA Oversight of Extended Reality Devices

On April 8, 2020, the American College of Radiology® (ACR®) filed comments with the Food and Drug Administration (FDA) regarding its March 5 public workshop exploring evaluation practices for virtual and augmented reality medical devices. The workshop and corresponding comment submissions will inform the agency’s oversight approaches to extended reality solutions used in radiology and other medical specialties.

Although many current implementations of extended reality in radiology are used exclusively for training purposes, the ACR’s comments focused on diagnostic and interventional radiology applications that would likely meet the statutory “medical device” definition and fall within the agency’s jurisdiction. Examples of such devices would be virtual displays, mixed reality radiology workstation interfaces, navigational overlays during interventional radiology procedures, and other current or future technologies.

For all such devices, the ACR urged the FDA to carefully consider customizability and ergonomics for wearable hardware, the short- and long-term physical/psychophysical safety of use and the potential negative effects that end users’ fatigue or cyber sickness might have on patient safety.

For diagnostic radiology, the ACR emphasized the need for virtual displays to have appropriately high resolution, fully featured calibration functionalities akin to hardware workstation displays and environmental testing/calibration methodologies akin to mobile medical application displays.

For interventional radiology, the ACR also pointed out the need for the FDA to consider the additional risk of wearable hardware and mixed reality visuals within the suite.

Moving forward, the ACR will continue to emphasize the need for regulators to prioritize patient safety as well as the personal safety, health and effectiveness of the physician end users of these products. The ACR anticipates there will be many other future opportunities for public feedback on FDA oversight of extended reality devices.