FDA Releases Guidance on Mobile Medical Apps

The FDA has released guidance that describes its planned approach to regulating mobile medical apps. The guidance is generally favorable to developers. FDA has stated that it will not regulate the work of most developers, since most apps are unlikely to pose a health risk to consumers.

The guidance excludes some types of mobile apps from its coverage, especially general mobile platforms and reference materials. It also provides examples of the kinds of apps that are covered. A list of some of these apps can be found here. Developers of apps used in the healthcare industry should review this guidance to decide if they need to take further action.

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