By Jon Wilderson, Senior CQV Engineer


With the increase in wearable technology and a focus on managing medical related diagnostics with smartphone apps, it can be difficult to decipher if the FDA regulates your device. By answering the 3 questions below, you can determine if you are really dealing with a mobile medical app and how to move forward if you are.

1.  Is my device classified as a mobile medical app?
According to the FDA, Mobile medical apps are medical devices that are mobile apps, meet the definition of a medical device, and are an accessory to a regulated medical device or transform a mobile platform into a regulated medical device.

2.  If my device is a mobile medical app, how will the FDA regulate it?
Similar to medical devices regulations, the FDA will apply the same risk-based approach in order to ensure safety and effectiveness.  However, the FDA’s mobile medical apps policy does not regulate smartphone/tablet manufacturers, mobile platform manufacturers, or app distributors.  Therefore, the responsibility falls to the mobile medical app developer.

The FDA will focus on mobile medical apps that can pose a greater risk to patients and these apps require premarket review applications.  Examples include:

  • Cardiac monitor
  • Arrhythmia detector
  • Electrocardiograph
  • Blood Pressure Measurement System
  • Glucose Measurement System
  • Oximeter
  • Infusion pump
  • Nebulizer

According to the FDA, Examples of mobile medical apps, which meet the regulatory definition of a “device” but pose minor risk to patients include:

  • Interactions with Personal Health Records or Electronic Health Systems
  • Patient self-management of a disease or condition without provision of specific treatment
  • Patient communication of potential medical conditions with their healthcare provider

3.  How do I handle OS updates and impact on mobile medical applications?
One of the biggest challenges with mobile medical applications is the ever-changing OS updates and its impact on the app. Major OS updates developers usually can receive beta versions of the OS in order to flush out any potential issues with the app.  However, minor OS patches are not made available prior to their release. Therefore, the need to ensure that a nimble and robust regression testing protocol or automated script is in place to test the critical aspects of your app is paramount to maintaining a quality controlled app.

To learn more, visit our Software & Hardware Testing page or contact us today for a free consultation with a member of our team.

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