Insights

Smartwatch health monitoring technology illustrating the distinction between wellness products and FDA-regulated medical devices.

October 1, 2026

Wellness Product vs Medical Device? Where U.S. FDA Draws the Line

Introduction Your wearable tracks your sleep. It reminds users to exercise, improve nutrition, and manage stress. Investors call it a digital health platform. Marketing calls it a wellness solution. But when does U.S. FDA view it as a medical device? That question sits at the center of FDA's General Wellness: Policy for Low-Risk Devices (Jan [...]

By: Yuka Osada
On: October 1, 2026

Wellness Product vs Medical Device? Where U.S. FDA Draws the Line

By: Yuka Osada
On: September 24, 2026

FDA’s CDRP Program: Faster CMC Development Through FDA Engagement

By: Yuka Osada
On: September 18, 2026

BLA Supports NovaSpira’s Bispecific Antibody NS-342 in Securing Phase I Clinical Trial Approval from South Korea’s MFDS

NovaSpira's bispecific antibody NS-342 received Phase I clinical trial approval from South Korea's MFDS, advancing a promising new treatment for...