Today, the U.S. Food and Drug Administration (FDA) is sharing a list of augmented reality and virtual reality (AR/VR) medical devices legally marketed in the U.S. through 510(k) clearance, De Novo classification, or Premarket Application Approval. The Center for Devices and Radiological Health’s Digital Health Center of Excellence developed this list to increase transparency and access to information on AR/VR medical devices.
Although not a comprehensive list, the information provided by the FDA is in response to recommendations received during the CDRH Patient Engagement Advisory Committee (PEAC) meeting held July 12-13, 2022, on the topic of AR/VR.
The list has information on AR/VR-based devices such as:
- Submission number
- Device and company name
- Date of marketing authorization of the device (510(k) clearance, granted De Novo request, or Premarket Approval)
