Publication Date

12-2017

Document Type

Article

Abstract

The integration of mobile health (mHealth) technologies into wellness and healthcare practices presents both opportunities and regulatory challenges. This article explores the role of the U.S. Food and Drug Administration (FDA) in regulating mHealth and wellness devices, particularly as technological advancements blur the lines between general wellness tools and medical devices. It examines the FDA's framework under the Food, Drug, and Cosmetic Act (FDCA) for classifying and overseeing devices based on intended use and associated risks, including the distinctions between medical devices and low-risk wellness products. Guidance documents for mobile medical applications and low-risk wellness devices are analyzed, highlighting their implications for developers, manufacturers, and wellness professionals. The article underscores the importance of compliance with FDA regulations while navigating evolving legal and technological landscapes in mHealth, emphasizing the need for awareness among stakeholders to foster innovation while ensuring consumer safety.

Publication Title

Health Lawyer

Volume

30

Issue

2

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