Virtual Reality as a Medical Device

by | Jan 24, 2020 | FDA, Medical Devices, Regulatory, Requirements

Augmented and virtual reality first saw its boom in the consumer sector but has recently piqued the interest of the medical device community. Extended reality (or XR, the umbrella term for augmented or virtual reality) can have many uses across the medical device and healthcare space. With a wide variety of applications and features, many med device firms are turning to it with the aim of advancing the industry.

Many medical device firms are utilizing XR as the basis for their medical device. Intuitive Surgical was granted FDA clearance last year for its product IRIS, which is used by surgeons to view 3D images of patient anatomy during procedures. There are also startups like Limbix which uses a VR headset to treat mental illnesses such as panic disorders.1Many companies are also turning to XR to assist with at home medical devices (which you can read more about here) in terms of training and patient instructions. Since medical device instructions can sometimes be hard to interpret based on a variety of factors, at home medical device firms are using XR to simulate hands-on training scenarios for customers.2

But how is XR regulated as a medical device? Since it’s such a novel field, the FDA is still actively working with medical device firms to effectively regulate the technology and allow for safer innovation. For now, most XR medical device firms are going the De Novo route, as the whole field is still new in the medical space and there aren’t a lot of predicate devices on the market. In March, the FDA is hosting a public workshop on medical extended reality, where it will host speakers from a variety of sectors and companies to discuss best evaluation practices for the technology.3 The agency is requesting comments from start-up companies and the public to help guide the conversation. With all of the emerging opportunities that XR medical devices could provide advancement in, the FDA wants to quickly figure out the most effective way to evaluate the products while still keeping consumers safe.

Much like 3D printed medical devices, XR medical devices are the new wave of the industry. The technology could potentially provide advancements to both health care providers and consumers alike that wouldn’t be possible without otherwise. If you are a medical device developer that is looking to utilize innovative technology such as XR, contact EMMA International at info@emmainternational.com or call (248) 987-4497  to see how we can help you navigate the regulatory pathway.


1Limbix (n.d.) Prescription Digital Therapeutics retrieved on 01/21/2020 from: https://www.limbix.com/pipeline

2DiGiulio, NBC News (August 2017) 3 Ways Virtual Reality Is Transforming Medical Care retrieved on 01/21/2020 from: https://www.nbcnews.com/mach/science/3-ways-virtual-reality-transforming-medical-care-ncna794871

3FDA (n.d.) Public Workshop – Medical Extended Reality: Toward Best Evaluation Practices for Virtual and Augmented Reality in Medicine retrieved on 01/22/2020 from: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/public-workshop-medical-extended-reality-toward-best-evaluation-practices-virtual-and-augmented

Madison Wheeler

Madison Wheeler

Director of Technical Operations - Ms. Wheeler serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Ms. Wheeler also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Ms. Wheeler holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA), and is currently pursuing her M.S. in Quality Management.

More Resources

De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.

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