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Medical Device Mobile Apps: Meeting the FDA Requirements

December 2012
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Just because a program or an app is running on an unregulated phone or tablet doesn’t mean that the app itself isn’t a medical device in the FDA's eyes. Like it or not, the FDA has made that clear.

What’s not so clear? Where the agency draws the line between unregulated products and those the FDA must approve.

Until now.

With its guidance on apps, the FDA declared health-related apps fall under its jurisdiction — just like any software that is intended to assist in diagnosing or treating an illness.

That means developers of health-related mobile apps for use on tablets and smartphones need to assess their apps to determine if FDA views them as a medical device. And, if it does, what the regulatory obligations are.

But how does the FDA differentiate between an app that specifically treats a person and one that just offers general advice? Are there ways to position an app so that it doesn't require approval? And if your app does need approval, how should you proceed and what should you expect?

Medical Device Mobile Apps: Meeting the FDA Requirements has the answers you need to such questions as:

  • How can you tell if an app falls under FDA jurisdiction?
  • Does an app requiring FDA approval need a full application or can the company follow the 510(k) route?
  • Will FDA approval delay an app so long that it becomes obsolete before it can be marketed?
  • What does the agency’s “enforcement discretion” mean in terms of some apps possibly falling under the definition of a traditional medical device”
  • How long will approval take and how much will it cost?

With Medical Device Mobile Apps: Meeting the FDA Requirements, your mHealth project will stay on schedule and in compliance.

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