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FDA Takes Control of Medical Apps




The U.S. Food and Drug Administration (FDA) plans to regulate parts of the mobile medical app industry.

An estimate by Research2Guidance shows that 500 million smart phone users worldwide will be using a health care application by 2015.

According to Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health, the FDA will oversee “only those mobile medical apps that present the greatest risk to patients when they don’t work as intended.”

The FDA aims to regulate the apps physicians use most often to diagnose or monitor a patient’s condition. These include:

  • apps that are used as an accessory to a medical device already regulated by the FDA, such as ultrasound equipment
  • apps that transform a mobile communications device into a regulated medical device through attachments, sensors or other devices, such as a blood glucose meter

The FDA is seeking public input. To submit a comment, visit www.fda.gov.


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