As part of its effort to support the future development and use of innovative, safe, and effective medical devices, the U.S. Food and Drug Administration (FDA) has updated several of its lists of medical devices that incorporate digital technologies.
The FDA’s update includes the following lists:
- The Artificial Intelligence (AI)-Enabled Medical Device List
- The Augmented Reality/Virtual Reality (AR/VR) Medical Device List
- The Sensor-Based Digital Health Technology (sDHT) Device List
Each of the FDA’s updated lists includes devices that have been authorized by the agency for marketing in the U.S.
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In addition to fostering the development of new digital health devices, the FDA says that the updated lists can provide healthcare providers with a better understanding of the current device landscape, thereby encouraging informed use of these advanced technologies in the treatment of patients.
Access the FDA’s updated device lists:
- AI-Enabled Medical Devices: https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices
- AR/VR Medical Devices: https://www.fda.gov/medical-devices/digital-health-center-excellence/augmented-reality-and-virtual-reality-medical-devices
- Sensor-Based Digital Health Technology: https://www.fda.gov/medical-devices/digital-health-center-excellence/medical-devices-incorporate-sensor-based-digital-health-technology