Augmented reality (AR) and virtual reality (VR) medical devices are being integrated into the medical field at an accelerating rate. On July 12th and 13th, 2022, the FDA held a Patient Engagement Advisory Committee (PEAC) meeting to consider the capabilities, risks, and benefits of these devices. This blog will provide an overview of the FDA’s discussion and what it means for Sponsors

In their 2022 meeting, FDA provided its take on the following questions:

First off, what are Augmented Reality (AR) and Virtual Reality (VR) medical devices?

Per FDA, AR/VR medical devices are typically snug-fitting headset devices that provide audio and visual output. In addition, some contain scent technologies or other sensory information.

Secondly, how can these devices be used in the medical field?

FDA described several types of treatment where AR/VR technology may be useful, including:

• Attention diversion for pain management
• Exposure therapies for phobias
• Situational confidence training for addiction
• Visualization components for physical rehab
• The creation of mindful calm environments for health and wellness

Thirdly, what effects are these devices likely to have on the healthcare industry?

Two notable benefits outside of actual treatments are increased transparency with patients and expansion of medical training.

Virtual reality opens the door for increased transparency, as patients can watch their surgeon walk through their procedure and demonstrate exactly what will happen, which can be difficult with 2D diagrams or explanations.

Along these same lines, extended reality medical training can create a rich, immersive environment for students using 3D models and computer feedback. Students can also virtually train with equipment that can be complex or unavailable. In addition, it can reduce the real-world impact of potential mistakes.

In addition, AR/VR has the potential to expand to include other biofeedback, such as touch, and may simulate physically impossible scenarios and environments that hold therapeutic efficacy.

Other interfaces, not previously possible, may now be made possible, such as “VR Pharmacies,” where patients can select a variety of treatments for pain management, mental health treatment, and more, all from the comfort and relative safety of their home.

Of course, no therapy comes without the associated risk. FDA also outlined some of their considerations for AR/VR medical devices.

Physical symptoms

The number one negative or untoward physical symptom is nausea.

Other physical concerns include eye strain, headache, and fatigue, which may occur due to the high volume of visual information processing that is required.

In addition, FDA noted that disorientation with the real environment might cause falls and collisions.

There is also concern AR/VR devices may have an addictive quality like other screen-based interfaces, including cell phones and TV.

Pediatric concerns

Per FDA, pediatric concerns fall into 2 main categories.

The first is an inability or hesitancy in children to report negative effects of the device, including sensitivity to the eyes and strain due to the device being too tight or heavy.

The second is neurodevelopmental concerns pertaining to the amount of required screen time and the potential for addiction. There is also some evidence that children should not be close to radio frequency emitting devices. It is thought that due to their thinner skulls, children’s brains absorb more radiation, which could cause DNA and other brain damage.

Unequal distribution

There are additional concerns that AR/VR devices will inevitably come with a high price tag and may cause further class stratification when it comes to access to these devices.

For instance, those who are employed with good medical insurance may be able to purchase a device, but those without it may not. Similarly, communities with limited internet access or underfunded clinics may also have limited, if any, access to such devices.

Finally, even if these hurdles are crossed, some populations may lack the digital education or tech-savvy skills to use AR/VR devices.

The shifting political climate and awareness of these issues may allow for prioritization, with the mindset of equity and success for everyone, for example, by considering methods to reduce the price for lower-income communities, increase the availability of digital literacy courses, or increase access in low-access areas.

Other Unanswered Questions

There are also many unanswered questions around data privacy and hardware and software considerations that FDA will have to address as AR/VR devices become more common:

• Will the headset company collect, store, or sell your data? How would you know, and who will regulate this? What cyber security do they have to stop potential hackers from accessing your data?
• Will the devices require high-speed internet? Will they need constant software and hardware updates that will compromise treatment?

Regulatory Considerations

For the most part, this technology will fall under the same categories as many other medical devices, such as 510(k)s, where the Sponsor must demonstrate “substantial equivalence”, or de novo requests where the device must demonstrate “reasonable assurance of safety and effectiveness.”

Regardless of the regulatory path, labeling information should be carefully considered to help caregivers, patients, and/or healthcare professionals understand how to use a device correctly and safely.

Another regulatory consideration is medical device safety reporting.

Medical device reporting includes mandatory, voluntary, & hospital-based reports.

Post-market surveillance studies may also be required, including post-approval studies for the device.

For post-market surveillance, there also may be communication with National Evaluation System for Health Technologies (NEST), which consolidates clinical registries, and other sources to support regulatory decision-making throughout the total product lifecycle.

What this means for Sponsors:

The key takeaways from this meeting for sponsors are to be aware of risks and possible adverse events associated with this novel device category and to carefully design trails around these.

For example, sponsors should select investigators who thoroughly understand the technology, and the trial design should include a range of tech-savvy participants. Trials should also be designed to ensure data and feedback are being received from both the participants and the devices themselves.

Other risks that Sponsors should proactively plan to address include anticipating how different device malfunctions may affect data and how such data should be collected, evaluated, and reported.

By: Aaron Pyle, Regulatory Affairs Associate

If you have any questions about regulatory operations, please email info@mmsholdings.com to speak with an expert.