Regulatory Landscape For Mobile Medical Apps (MMAs)


On December 6, 2013, I delivered a presentation on the FDA’s policy on mobile medical apps (MMA) to the Bar Association of Erie County. The event was well attended by attorneys practicing in diverse areas, including health, intellectual property, personal injury, and business law.

The program began with an introduction of the regulatory process for medical devices in general, leading the discussion into regulation of software and MMAs as medical devices to an overview of the FDA’s regulatory history with respect to computing devices. During the course of the presentation, I also discussed the FDA’s 2011 guidance for MMAs and the industry’s concerns stemming from the 2011 guidance, which led to the Congressional hearing on the subject in early 2013, ultimately resulting in the FDA issuing its final policy on MMAs in September 2013. The presentation concluded with an informative question and answer session on compliance trends in the MMA industry and the pattern of enforcement actions against the manufacturers and developers of mobile medical apps.

For more information on the FDA policy on MMAs, please review my presentation, or visit the FDA’s website to check out the guidance documents first hand (links to specific documents are included at the end of my presentation).


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.

© Hodgson Russ LLP | 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.