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Navigating Mobile Medical Apps: Intouch Makes it Easy

Wendy Blackburn

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Your team has a great idea for a new app. And you know that the FDA has, at last, issued final guidance for mobile medical apps. It sounds like you’re ready to go. But, when you stop and think about it, you’re still not quite sure of the details. What exactly does the FDA guidance mean for you and your new idea? How should you proceed?

Is a mobile app a good investment for a brand?

If devoting the time, resources, and patience to sift through 43 pages of guidance seems daunting, fear not. Intouch Solutions experts have developed a new decision tree to help determine whether a healthcare app may need to go through 510k clearance.

The app development process can be lengthy, painstaking, and expensive — especially if the FDA deems the app to be a medical device. So Intouch is here to assist in the determination: is the idea worth the investment in the first place?

Our decision tree provides a road map for considering the most important questions, and ensuring that all of the important issues are addressed.

  • Is an app the best solution for the brand’s needs?
  • Could the app be considered a medical device?
  • Will it fall into a category that the FDA intends to regulate?
  • Will it require 510(k) clearance?

The decision tree begins the conversation. What happens next, though?

Mobile apps in healthcare are a complex arena of burgeoning brilliance. They have the potential to be truly life-changing for patients and clinicians: to help manage chronic diseases, to help properly treat diseases, to diagnose new conditions, and perhaps even to prevent illness in the first place.

That’s why It’s vital to have an experienced partner helping navigate these new waters. When a marketer decides to pursue an app concept, they must to be sure to have a team on hand who can find the right answers to questions like these:

  • The guidance applies only to apps that are considered to be medical devices, or accessories to medical devices. Does that apply to this app?
  • If the app is a mobile medical app — what next? What are the proper steps to secure regulatory approval when it comes to documentation, development, testing, and the submission?
  • If the app isn’t a mobile medical app, what does that mean? Is it off the hook entirely, or is there still work to do — and if so, what?
  • What can change how the app is classified and what regulations apply to it? How will future updates, or even the ways in which the app is promoted, affect its standing?
  • Which parties are considered mobile medical app manufacturers, and which aren’t? What regulations apply to the different parties?

The mobile-app industry is nearing $25 billion and showing no signs of slowing  — and It’s expected that within five years, healthcare apps alone will near that total. Bringing brands into the app space is becoming less of a choice and more of a requirement. We hope our new decision tree is a useful new tool to help do just that.


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