What is a Wearable Device? Lifestyle Device vs. Medical Device

Posted 17 January 2017 By Meredith May, MS, RAC, Anna C. McFadden, PhD

placeholder+image This article discusses how to determine when wearable lifestyle devices, referred to as fitness trackers, might be categorized as medical devices. In cases where fitness trackers are used in particular ways, their categorization as a medical device carries with it specific requirements for compliance to regulations. The article provides useful information to regulatory personnel in assessing how much compliance to the Health Insurance Privacy and Portability Act (HIPPA)1 is expected for a wearable lifestyle device or fitness tracker with imbedded software when used for specific purposes. The article also reviews the migration from lifestyle device to medical device and the accompanying regulatory implications, including FDA's 'intended use.' The concept of "intended use" is key in making the distinction between lifestyle device and medical device, as in the case of wearable fitness devices.2, 3

Share this article:

Categories: Medical Devices, Features, US, FDA

Tags: Wearables, Fitness tracker, Lifestyle devices

Regulatory Exchange: Latest Updates From the Community