Wearables vs. Regulated Medical Devices under the US FDA

One of the biggest challenges for companies in the general wellness space is understanding how and when their technology might encounter FDA regulatory scrutiny. In July 2016, the FDA issued a guidance document dealing with the rapidly growing market of wellness products, which includes activity trackers, smart watches, and other products intended to help monitor and improve consumers’ physical fitness, nutrition, or other wellness goals.

This white paper examines the FDA guidance document on “general wellness products” and discusses the nuances that determine if a product intended to improve health and fitness is a regulated medical device.