FDA Creates New List That Includes Digital Health Technologies

The FDA has promoted a new innovation and safety in medical devices, including those using digital health technologies (DHTs), by publishing searchable lists of authorized devices.

Key Updates:

• An updated list of artificial intelligence-enabled medical devices.
• An updated list of medical devices that incorporate augmented reality and virtual reality.
• A new list of sensor-based digital health technology medical devices.

Use and Benefits

• For Innovators: Gain insight into the regulatory landscape and device trends to guide development.
• For Healthcare Providers & Patients: Promote transparency and awareness of devices incorporating DHTs.

To note:

• These lists are not exhaustive.
• Devices are included based on information from marketing authorization documents.
• The FDA updates the lists periodically.

The full FDA post is here: Updated and New Lists of Medical Devices that Incorporate Digital Health Technologies.

How MedEnvoy Can Support

MedEnvoy offers expert regulatory support to manufacturers in navigating FDA requirements and compliance. If you have any questions regarding the above, we encourage you to reach out to our regulatory experts here.