Search Results for Wearables

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What is a Wearable Device? Lifestyle Device vs. Medical Device By Meredith May, MS, RAC, Anna C. McFadden, PhD - Published 17 January 2017

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

Categories: Features, US, FDA, Medical Devices

Tags: Wearables, Fitness tracker, Lifestyle devices

Lingering Questions About Medical Apps By Michael Mezher - Published 09 July 2015

In recent years, the US Food and Drug Administration (FDA) has issued several guidance documents attempting to clarify its approach to regulating medical apps. However, the authors of "A regulatory framework emerges for digital medicine," a commentary appearing in Nature this week, raise several regulatory challenges remaining unanswered.

Categories: News, US, FDA, Clinical, Medical Devices, Regulatory strategy, Submission and registration

Tags: Medical apps, Medical applications, Mobile applications, digital health software, wearables