Publication Date

2-2018

Document Type

Article

Abstract

This article provides an update on the evolving regulatory landscape of mobile health (mHealth) and wellness devices, focusing on changes introduced by the Food and Drug Administration (FDA) through its 2017 Draft Guidance. These updates aim to clarify inconsistencies in the definitions and regulatory status of various categories of devices, such as mobile medical apps, general mobile apps, and low-risk wellness devices. The Draft Guidance redefines certain wellness devices, emphasizing that those related to chronic diseases or conditions may now be recognized as medical devices but remain under FDA's enforcement discretion if they pose minimal safety risks. Additionally, the article discusses the FDA's decision to exempt specific mobile apps promoting general health and wellness from medical device classification, thereby removing them from regulatory oversight. These changes highlight the dynamic intersection of technology, health, and regulation, urging stakeholders to remain informed and compliant with the FDA's evolving policies.

Publication Title

Health Lawyer

Volume

30

Issue

3

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