FDA finally publishes final guidance for mobile medical apps

By: Brian Dolan | Sep 23, 2013        

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PillPhone: One of the first patient-facing mobile apps to get FDA clearance.

PillPhone: One of the first patient-facing mobile apps to get FDA clearance.

Last week when departing ONC chief Dr. Farzad Mostashari told MobiHealthNews that he thought the FDA should release its final guidance document for mobile medical apps without delay, he might have known something we didn’t.

After more than two years since the FDA first published its draft guidance on how it regulates mobile medical applications, the agency announced this morning that it had published its final guidance on the regulation of mobile medical apps. Notably, the FDA published its final guidance document just before the end of September, which would have marked the end of the agency’s fiscal year. At the congressional hearings earlier this year, the FDA more or less promised to get the guidance out before the end of its fiscal year.

The overall message from the FDA has not changed much since it first published its draft guidance — the final document is nonbinding and explanatory in nature. It also focuses on a small subset of medical apps “that present a greater risk to patients if they do not work as intended,” the agency wrote in a press release.

The two broad categories of apps that the FDA regulates, according to the final guidance, are:

1. are intended to be used as an accessory to a regulated medical device – for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet; or

2. transform a mobile platform into a regulated medical device – for example, an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.

As it noted during Congressional hearings earlier this year, the FDA has already cleared about 100 mobile medical applications over the course of the last 10 years or so — about 40 FDA-cleared apps received their clearance in the past two years, according to the FDA. As a former FDA director once advised in 2011, at least a few dozen developers didn’t wait for the final guidance document to drop to create their wares.

Shortly before the FDA published its draft guidance document in mid- to late 2011, the Federal Trade Commission moved to remove two health-related apps from Apple’s AppStore and Google’s Play store, then called the Android Market. Both the apps were paid apps that promised to help cure user’s acne via a blue light emitted from their phones’ screens. While these apps were not found to be necessarily harmful to the user’s health, the FTC argued they were based on specious claims.

The FDA also published an important guidance document for mobile health devicemakers — the hardware side of the industry — in August. The guidance on device interoperability had been in the works even longer than the mobile medical apps document.

Read the FDA’s final guidance for mobile medical apps here. (PDF)

For more on regulated apps, check out our report: 75 FDA-cleared Mobile Medical Apps.

  • MikeZ

    First take away – few surprises.

    The guidance provides a good list of examples of non-medical-device apps, “Discretion Apps” and app clearly falling under regulations.
    It may be a surprise that many of the wellness apps such as calorie and activity trackers, or motivation apps are listed as “Discretion Apps”.

    This would have a huge impact on many developers and manufacturers as this group of applications require to follow most of the General Controls such as Device Registrations and Listing, Labeling Requirements, Adverse Event Reporting, and most importantly Quality Systems.

    There is however a footnote (#32) which “clarifies” that “When these items are not marketed, promoted or intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or do not otherwise meet the definition of medical device, FDA does not regulate them”
    Otherwise, FDA intends to exercise enforcement discretion.

    It seems then that developers and investors with “Discretion Apps” who were looking to get more clarity, received little. And we’re back to crafty boiler-plate disclaimers stating that “This App is not a medical device”

  • MobiHealthNews


    My reading of that is:

    If tracking apps like the ones you reference above DON’T claim to be used to cure or prevent or mitigate a particular disease — the FDA won’t regulate them. If they DO make that claim, the FDA will CHOOSE NOT to regulate them via enforcement discretion. However, if they DO make those claims the FDA “recommends” they follow quality systems (this is clarified in FAQ) so they don’t hurt users somehow. Just a recommendation — not a requirement.

    Like you, I’m assuming, I’ve only had a few hours with this document. Do you think I’m reading it right?


  • MikeZ

    I think you’re reading it right. During my first read I did not notice the soft “should” language regarding the Quality System.

    I see two problems with this scenario. First, the confusion related to what meets and what does not meet the definition e.g. when a calorie tracker does become a medical device. To regulatory professionals it may not be as confusing as it is to developers with little regulatory knowledge.
    Second, if a quality system is only a recommendation, guess how many companies will choose to spend the extra cash and resources to implement it.

    I may be biased towards more regulation, but I represent a company that decided to follow the FDA regulations, even though most competitors do not, because we believe that compliance with the Regulations is currently the only objective way to demonstrate safety and effectiveness of mobile medical apps.

  • MobiHealthNews

    I hear you, but can’t imagine the FDA ever saying: This group of apps — you all don’t have to worry about patient safety. I also believe this type of rulemaking is inevitably nuanced — this document is more clear than the last but I don’t think it’s possible to ever make it black and white.