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FDA Issues Final Guidance on Mobile Medical Apps

October 24, 2013 No Comments

SOURCE: Sway Medical


by Michael Zagorski

The FDA final guidance on Mobile Medical Applications is finally here. The final document effectively creates three categories of mobile applications in the mobile health space:

1. Apps not considered to be medical devices such as educational, reference, and training apps, or apps for   general office management and administration

2. Apps that meet the definition of a medical device, but due to the low risk nature the FDA has decided not to pursue regulation at this time

3. Apps that meet the definition of a medical device and may pose risk to patients and therefore fall under FDA’s oversight (Discretion Apps)

The first two groups offer little surprise. Historically the FDA has not regulated general administrative or reference apps and nothing indicated this would change. On the other hand, FDA has focused on the functionality rather than platform, so, if a device, whether hardware, or a software, or an accessory met a definition of a medical device, the FDA would expect compliance with the regulations.

Somewhat unexpected action by the FDA was the creation of category of apps under “enforcement discretion”, such as exercise and fitness apps, smoking cessation, dietary and calorie tracking, location based asthma applications, and activity trackers. All these apps would be considered medical devices depending on the claims made by the manufacturer; however the FDA has not provided any more detail around that.

By placing these apps under “Enforcement Discretion” the FDA provides developers time to plan for and establish quality and regulatory processes required by General and Special Controls, and probably the FDA itself to provide clearer guidance and determine how to enforce regulations for all these apps. Under the enforcement discretion, the FDA will not require manufacturer to submit a pre-market application or comply with other general controls such as Quality System Regulation, for the time being.

Creation of the “Discretion Apps” group is generally good news for the developers of this type of apps; however it eliminates probably the only objective information whether the application performs as the developer or the manufacturer claims the app does. Not to say that all developers create inferior applications, but with so many applications out there and some of them being created by teams consisting of only one or two people, there is a real need for a comprehensive certification process to provide a respected review of apps to ensure data will be safe and the applications will perform as expected.

What’s next?

Now that the final guidance is here, the FDA may now begin to take more direct regulatory action towards mobile health app makers not in compliance, though not failing to recognize that it may take some time for players new to the regulated space to determine applicable regulatory requirements.

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