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FDA Issues Final Guidance on Mobile Medical Apps

On September 23, 2013, the U.S. Food and Drug Administration (FDA) issued final guidance governing the development of mobile medical apps. The FDA will focus its oversight on apps that it deems potentially harmful to consumers if they do not function properly. This, therefore, largely excludes the majority of medically-oriented mobile apps currently on the market as they pose minimal risk to consumers.

Specifically, the FDA said that it will only regulate apps that allow smartphones to function in a manner similar to those devices the agency now regulates.  For example, the FDA will monitor apps that purport to allow a smartphone to function as an electrocardiography machine. It will also regulate apps intended to be used as an accessory to a regulated device, such as one that allows doctors to view images that are used to diagnose patients.

Further, the FDA stated that it will not regulate the devices that utilize apps, such as smartphones and tablet devices themselves, nor will it regulate distributors of apps such as iTunes or Google Play.

Apps that fall within the FDA's regulatory oversight will need to be cleared by the FDA prior to being allowed on the market. According to the FDA, the agency has cleared approximately 100 medical apps over the past decade.

These final rules come more than two years after the FDA released proposed guidance in which the FDA proposed regulating any app that it deemed to be a medical device. The FDA received more than 130 comments on the proposed guidance.

If you'd like to review the final mobile medical apps guidance, it is available here.

If you have questions about the guidance, please contact Samuel J. Frederick at 517.371.8103 or Nicole E. Stratton at 517.371.8140.

Categories: Regulatory


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