FDA Policy for Mobile Medical Applications

Lexology February 14, 2020
Nossaman LLP

Introduction

The start-up segment of our healthcare regulatory practice is focused on companies bringing digital health tools to market. As part of the efforts of the U.S. Food and Drug Administration (“FDA” or the “agency”) to clarify its regulatory stance on digital health tools, the agency released a revised guidance in 2019 entitled, Policy for Device Software Functions and Mobile Medical Applications – Guidance for Industry and Food and Drug Administration Staff (the “Guidance”).¹ Not a regulation resulting from formal rulemaking, the Guidance (in the FDA’s own words) does “not establish legally enforceable responsibilities” and “should be viewed only as recommendations.”² Even so, it is a valuable communication to inform us of the agency’s regulatory approach to mobile applications.

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