On Sept. 23, 2013 the FDA issued a press release for its final guidance on Mobile Medical Applications (MMA). This guidance is the outcome of the draft issued July 21, 2011 and the result of comments received and FDA analysis over that period. For healthcare marketers the interesting points are what has changed, and what hasn’t (compare to our previous coverage). Specifically interesting are the app types that won’t be regulated (below).
The guidance states explicitly that if this changes in the future there will be a “public process” so all parties will be informed of the change and have time to adapt. This statement should eliminate the feelings of uncertainty in the market and allow anyone “sitting on the fence” to make a decision on their MMA projects.
What qualifies as a Mobile Medical App (MMA)?
The rules haven’t changed since the draft document, but the FDA has provided more clarity around what does and does not qualify as a device (and subsequently needs 510(k) approval). The key criteria for the FDA is whether an app’s “functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended.”
Apps that do the following are considered MMAs and require approval:
- Apps that extend a medical device by controlling it or displaying or transferring its data (providing instructions for the device is not considered an MMA)
- Apps that use “plug-in” sensors or devices that provide functionality regulated by the FDA such as glucose readers such as iBGStar
- Apps that use sensors built into the device such as motion detectors, mics, cameras, etc. to perform a function that is regulated by the FDA such as iHeart
- Apps that perform patient-specific analysis and provide treatment or diagnosis recommendations such as Multiple Sclerosis Diagnosis & Management
The final guidance also includes extensive explanations of the process that an MMA owner would follow to determine the class of MMA and the process by which they would get approvals. The document also references Accredited Persons who can assist the MMA owner. Using one of these companies ensures the FDA will respond within 30 days after getting the Accredited Persons’ recommendation.
What MMAs won’t be enforced?
Not all apps that fall under the FDA’s broad-reaching definition of an MMA will be regulated. The FDA is exercising “enforcement discretion” for some apps and will not be regulating them if they pose lower risks to the public.
Apps that do fall under the FDA’s definition of an MMA but which do not need approval are:
- Apps that help patients track their disease or condition, such as a calorie or weight loss tracker, as long as they do not provide specific treatment or treatment suggestions
- Apps that help patients document their condition for sharing with a healthcare professional, including those that work as telehealth extenders and share data with the HCP such as an app that sends photos of skin
- Apps that supplement clinical care through persuasive techniques, such as coaching and adherence reminder apps
- Apps that help healthcare providers communicate details to one another or to patients which can include images or video such as apps that replace patient educational material
- Simple calculators for healthcare providers (the key here is the definition of simple, they need to be in medical textbooks, dosing calculators ARE considered MMAs)
- Personal health records (PHRs) or simple tools to help patients organize their health information
- Information-only apps that do not have interactive tools
Note that while these apps are not regulated, the FDA does “strongly” recommend that app manufacturers follow the Quality System regulation so always check with your app provider that they understand these rules and have the necessary quality controls in place.
This final guidance shows that some apps that would have been considered regulated MMAs under the draft guidance are now being given a pass and that this decision will not be changed without a full public consultation process.
Healthcare companies can now feel confident in how to approach their mobile plans and produce apps that help healthcare providers, patients, and consumers understand their health and improve their lives.
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