September 25, 2017 |
Keeping Up with Progress in Mobile Medical Apps
September 24, 2013  | 

Rockville, MD - Patients with diabetes can already use smartphones to monitor the level of sugar in their blood, and doctors can whip out their tablets to read X-rays and perform ultrasounds or electrocardiograms.

Those functions represent just the tip of the iceberg in a coming revolution in mobile medical applications, or "apps," intended for use on mobile phones and tablets. The Food and Drug Administration (FDA) encourages innovation and is excited about the prospects that mobile medical apps offer for providing better care and greater patient involvement in their own health.

At the same time, FDA wants to ensure the safety and effectiveness of the small percentage of mobile medical apps that could be harmful if they didn't work properly.

FDA has issued a guidance document to give mobile app creators a clear and predictable roadmap to help them determine whether or not their products will be the focus of FDA's oversight. To protect consumers and encourage innovation, while at the same time providing the same level of confidence consumers have with other medical devices, the guidance document states that FDA will focus its oversight on medical mobile apps that meet the definition of device in the Federal Food, Drug, and Cosmetic Act and are intended to:

  • transform a mobile device into a medical device regulated by FDA; or
  • be used as an accessory to a medical device regulated by the FDA.

FDA intends to exercise enforcement discretion for other mobile apps. This focuses FDA's regulatory priorities on the small subset of mobile medical apps that could present a greater risk to health. Continue>

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