The FDA on Mobile Apps

Smartphone with cloud of application icons

Hello good people of the world! Today’s post is on the FDA’s guidance on Mobile Medical Applications, which can be found here. Mobile apps are becoming more and more a part of everyday life, and it only makes sense that they will be used in healthcare more as well. What are the FDA’s concerns around mobile apps?

This post covers FDA’s guidance issued on February 9, 2015. This version succeeds the previous version issued on September 25, 2013.

The document starts by recognizing the “extensive variety” of mobile apps, the “rapid pace of innovation,” and the “potential benefits and risks” to public health. The stated purpose is the for the FDA to clarify which subset of apps will fall under it’s authority.

The document then states that the majority of mobile apps are either 1. not medical devices, or 2. pose a lower risk to public health, therefore the FDA will “exercise enforcement discretion” over these devices.

The guidance defines “mobile medical apps” as “mobile app that are medical devices … whose functionality could pose a risk to a patients’ safety.” These are the apps the FDA will focus its oversight on.

Mobile medical apps will be expected to comply with the CFRs pertaining to medical devices, specifically:

  • 21CFR807 Establishing registration, and Medical Device listing
  • 21CFR820 Quality System (QS) regulation
  • 21CFR801 Labeling requirements
  • 21CFR803 Medical Device Reporting
  • 21CFR807 Premarket notification
  • 21CFR806 Reporting Corrections and Removals
  • 21CFR812 Investigational Device Exemption (IDE) requirements for clinical studies of investigational devices

What are your quality concerns around mobile applications?

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