03/23/2026
As FDA eases certain wellness-device oversight boundaries, manufacturers must strengthen validation and documentation.
Read more: https://cmdclabs.com/a-lighter-touch-heavier-responsibility-what-fdas-wellness-device-shift-really-means-for-manufacturers/
For years, the “wellness device” space has lived in a strange middle ground. On one side: booming consumer demand for wearables, health apps, sensor-driven insights, and AI-generated coaching. On the other: the realities of regulated healthcare—where accuracy, reliability, and documentation ar...