Regulatory Landscape For Mobile Medical Apps (MMAs)

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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).

 


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.

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