Will FDA Regulate Your Mobile Medical App?

Posted in Mobile Health by Jamie Hartford on August 6, 2014

This quick guide will help you determine if your app can slip through the regulatory cracks or if it must face FDA scrutiny. 

Mobile medical applications are one of the hottest health trends going. More than half a billion smartphone users are expected to be using mobile medical apps next year, and that number will climb to more than 1.7 billion by 2018, according to a report from Research2Guidance.  

It's no surprise, then, that the medical device industry is becoming increasingly interested in developing these apps. But FDA, too, has taken notice. In September 2013, the agency issued its Mobile Medical Applications Guidance for Industry and Staff to explain how it would approach regulation of this emerging field.

MD+DI editorial advisory board member Bradley Merrill Thompson, a member of law firm Epstein Becker & Green and head of the firm's Connected Health Initiative, has been following FDA's progress on mobile apps regulation. Together with Worrell, a product design, development, and strategy firm that collaborates with medical device companies and entrepreneurs, he developed the following infographic guide to help developers quickly and easily determine if their mobile medical apps can slip through the regulatory cracks or if they must face FDA scrutiny.

Will the FDA regulate my mobile app?

Jamie Hartford, managing editor, MD+DI

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Aiming for the cracks

The idea of intentionally seeking to slip through the cracks might warrant a reading of my MDDI article:

When Medical Device Companies Bend the Rules: What don't medical device makers do because they have figured out how to get away with not doing it?

Would you want to

Sure it will cost money and some time if scheduled wrongly, but my question is why you would want to "slip through the cracks". IMHO you have to be mentally defective to not follow every one of the regulations from the FDA, IEC, etc. in the development of your product, be it software, hardware or a combo of both.

Sure, the auditors can cost you big bucks, but I would sure suggest understanding what benefits a risk-based product development system brings. Do you really want to take a chance of giving wrong information to a patient or medical professional because you didn't know how they would use or not guard the underlying data?

If you want to not apply for the approvals from the FDA, OK, but run your company and your project as if you were -- those standards are far better than anything you could dream up by yourself.

If not ...hire a large service department and a great law firm.