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FDA Defines Its Authority Over Mobile Medical Apps

Margaret Dick Tocknell, for HealthLeaders Media, July 20, 2011

FDA has already cleared a handful of mobile medical apps used by physicians and other health care professionals, such as a smartphone-based ultrasound, an application for iPhones and iPads that allows doctors to view medical images and X-rays, and an app that can help diagnose and treat radiation injuries. The guidelines will not apply to apps that help consumers manage their own health and wellness, such as apps that track calorie intake and body weight.

In addition to safety concerns, the FDA said in the draft guidelines that it plans to take into account the technical limitations of mobile devices, such as small screen size and low contrast ratios, which might negatively affect the ability to accurately read images.

The FDA proposes these regulatory requirements for mobile medical application manufacturers:

  • Must register each year with the FDA and provide a list of the devices they market.
  • Must comply with applicable labeling regulations found in 21 CFR Part 801, and Part 809 for radiological health products.
  • Must follow direction from the FDA for testing and development of those mobile medical apps requiring clinical investigations to support marketing.
  • Must prepare and submit to the FDA an appropriate premarket submission as required for the device classification.
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