The United States Food and Drug Administration (FDA) has issued a list of augmented reality (AR) and virtual reality (VR) medical/dental devices legally marketed in the United States through FDA 510(k) clearance, De Novo classification, or Premarket Application Approval. The FDA Center for Devices and Radiological Health (CDRH) Digital Health Center of Excellence developed this list to increase transparency and access to information on AR/VR medical/dental 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. To read the FDA announcement and summary of its AR/VR medical/dental devices list, and to access the list, use the link below.
https://www.fda.gov/medical-devices/digital-health-center-excellence/augmented-reality-and-virtual-reality-medical-devices?utm_medium=email&utm_source=govdelivery