The FDA’S Crackdown on Wearables

The FDA’S Crackdown on Wearables

FDA wearables regulation

Two recent actions involving the United States Food and Drug Administration (FDA), in July 2025 – one, a FDA warning letter to WHOOP and the other, a Class I recall by Dexcom – are instructive in understanding the FDA’s evolving approach to Software as a Medical Device (SaMD) and connected health products. FDA’s oversight is […]

Leave Us A Message

Cookie Consent with Real Cookie Banner