How to get FDA approval for mobile medical apps

If your parents house is anything like mine, there are random health machines all over the place, mobile monitors of all sizes and shapes for monitoring blood pressure, ECG electrocardiograms, and god knows what. But smartphone apps are a-coming.

AliveCor mobile ECG monitor

Today I covered the FDA approval of the first smartphone operated, continuous ECG mobile monitor, eMotion ECG Mobile, for inventorSpot. While I was researching the multitude of competitors, I saw a few smartphone operated ECG’s, mainly for use by clinicians in their clinics. It made me wonder how the FDA is dealing with this influx of smartphone medical device apps.

Having trained and worked as a Biomedical Engineer, I can tell you from personal experience that the FDA approval process is no fun – when people’s lives are at stake, things tend to get serious. But as an iPhone app developer, the Apple approval process has at times been too much to take. I can’t imagine having to do both!

So it turns out the FDA released guidelines just a few months ago about how they are going to regulate what they call mobile medical apps.

And they have been dealing with an influx:

The agency has cleared about 100 mobile medical applications over the past decade; about 40 of those were cleared in the past two years.”

They’ve decided to focus their oversight on mobile medical apps that:

  • are intended to be used as an accessory to a regulated medical device – for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet; or
  • transform a mobile platform into a regulated medical device – for example, an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.

Mobile medical apps that undergo FDA review will be assessed using the same regulatory standards and risk-based approach that the agency applies to other medical devices.”

I guess that means it takes a long time to get mobile medical apps through the FDA, and will keep the barriers to entry high for the majority of aspiring mobile medical app inventors. Looks like my parents will be waiting a while before they can download mobile medical apps for everything they need right on their smartphone.

What medical devices are lying around your home? Do you have any cool ideas for medical device apps that you think should be built?

If you want to hear more about the latest in health and fitness technology inventions, you can find me writing over at inventorSpot


4 thoughts on “How to get FDA approval for mobile medical apps

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