FdaWellness DevicesMedical Devices
Your Smart Ring Is a Wellness Device, Not a Medical Device. Here's What That Actually Means.
The FDA's 19-page general wellness policy lets smart ring companies skip clinical validation entirely. Every wearable you have heard of lives inside that loophole. The difference between wellness and medical is not a matter of degree. It is a matter of whether anyone tested the accuracy before it shipped.
James Hoffmann May 31, 2026 · 12 min read