In general, apps that will be monitored by the FDA meet the definition of “medical device” as set forth by the Federal Food, Drug and Cosmetic Act, and are intended to either transform the mobile device into a medical device or be used as an accessory to a medical device.
For example, an app that calculates medication dosage would be seen as turning the mobile device into a medical device, and would be subject to the same FDA regulation as any other medical device that calculates medication dosage.
Apps that help a patient track health trends or monitor caloric intake, among other similar apps, are not currently the focus of the FDA’s regulation.
More Articles on FDA Regulations:
FDA Issues Final Regulations for Medical Device Tracking Codes
Michigan Bill Calls for FDA Regulation of Medical Apps
The Health IT Most Likely to be Subjected to FDA Regulation
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