Mobile Medical Apps: Keeping Up with the FDA’s Evolving Requirements

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Mobile Medical Apps
Keeping Up with the FDA’s Evolving Requirements

Your smart phone is not a medical device. Your tablet is not a medical device. Your fitbit is not a medical device. They’re not subject to FDA regulation.

But when you add mobile device applications that collect, interpret or transmit some kind of health-related data, this can launch you into the world of FDA regulation.

The app that helps you count calories is not a medical device.  But, what if that app transmits your calorie data to your physician? Does that make it a medical device?

Where does the FDA draw the line between unregulated products and those it must approve?

The final guidance for Mobile Medical Applications helps clarify the FDA’s position on regulating mobile apps, but leaves several areas open to interpretation.

You need to know:

  • How the FDA categorizes mobile apps and decides how — or whether — to regulate them as medical devices.
  • How the FDA evaluates an app’s “intended use.”
  • How to interpret the FDA’s promise of “enforcement discretion” for certain types of apps.
  • Who can be considered a mobile medical app developer and what regulations affect them.

This management report interprets the FDA’s evolving stance on mobile apps and explains how the FDA sorts mobile apps into three categories:

  1. Administrative health information technology (e.g, billing, claims processing, general communication and scheduling): This is not a medical device and not regulated by the agency.
  2. Health management information technology (e.g., medication management, data capture, electronic access to clinical results, provider order entry): This is under FDA jurisdiction but generally so low risk that the agency can exercise enforcement discretion and not apply regulations.
  3. Medical device health information technology (e.g., computer-aided detection and diagnosis, robotic surgical planning, remote display of bedside alarms, radiation treatment planning): This is actively regulated under Class I, Class II and Class III medical device rules.

Mobile Medical Apps explains what the FDA means by enforcement discretion and how it considers an app’s intended use in category assignment. Order your copy today.


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