New FDA Draft Guidance on Mobile Medical Apps Provides Some Clarity, But Raises Many More Questions


On July 19, the Food and Drug Administration (FDA) issued a new draft guidance document, titled Mobile Medical Applications, describing FDA’s position on the regulation of mobile applications, i.e., software applications intended to run on mobile platforms, such as smart phones, personal digital assistants, tablets, and other mobile computing devices. FDA stated that its proposed approach is intended to focus only on a small subset of mobile applications, or “apps,” that may impact the performance of currently regulated devices. To this end, the draft guidance provides some principles to apply and examples of the types of mobile apps that would be considered regulated medical devices. However, a number of uncertainties remain as to exactly where FDA draws the line between regulated and unregulated apps. Thus, although FDA stated intention is to concentrate on those mobile apps that present the greatest risk to patients, ambiguities in the draft guidance may hinder that objective.

In the new draft guidance, FDA defines a “mobile medical app” as a mobile app that (1) meets the definition of a “device” under the Federal Food, Drug, and Cosmetic Act (FFDCA) and (2) either (a) is used as an accessory to a regulated medical device or (b) transforms a mobile platform (such as a mobile phone) into a regulated medical device.

FDA states in the draft guidance that it intends to limit its regulation of mobile apps to those that fall within the definition of a “mobile medical app,” and that it would exercise enforcement discretion for other mobile apps that meet the definition of a “device” under the FFDCA but do not meet the definition of a “mobile medical app.”

Please see full article below for more information.

LOADING PDF: If there are any problems, click here to download the file.

Written by:

Published In:

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Morgan Lewis | Attorney Advertising

Don't miss a thing! Build a custom news brief:

Read fresh new writing on compliance, cybersecurity, Dodd-Frank, whistleblowers, social media, hiring & firing, patent reform, the NLRB, Obamacare, the SEC…

…or whatever matters the most to you. Follow authors, firms, and topics on JD Supra.

Create your news brief now - it's free and easy »

All the intelligence you need, in one easy email:

Great! Your first step to building an email digest of JD Supra authors and topics. Log in with LinkedIn so we can start sending your digest...

Sign up for your custom alerts now, using LinkedIn ›

* With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name.