Developing mobile medical applications doesn’t require you to be a major manufacturer of medical devices. Mobile apps and innovations by healthcare providers, insurance companies and individual physicians, make healthcare news on a regular basis – even Amazon.com is in on it. In the United States, all medical applications fall under the jurisdiction of the US Food and Drug Administration (FDA). The purpose of this article is to help you determine whether your medical app will require FDA approval. Failing that, you will save a lot of time finding the specific regulations and resources to cover some wide-ranging grey areas.
What does the FDA have to do with mobile apps? Quite a lot when it comes to mobile medical application approval, specifically.
The FDA’s mission is to protect public health by assuring the safety, effectiveness, and security of the national food supply, drugs, biological products, cosmetics, and medical devices.
So, before going deeper into the need for FDA approval of medical applications, it’s worthwhile to take a look at some numbers: [ Ссылка ]

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Disclaimer
The information provided herein is for general guidance only and is not intended to be legal advice.

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