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FDA Defines Its Authority Over Mobile Medical Apps

 |  By Margaret@example.com  
   July 20, 2011

The burgeoning mobile medical applications business got a look on Tuesday at how the government plans to regulate some of the industry.

The U.S. Food and Drug Administration's draft guidelines signal that of the thousands of mobile medical apps available today, it will seek to oversee only a small subset of apps – the ones physicians would most likely use to diagnose or monitor a patient's medical condition. These include applications that could impact how a currently regulated medical device (such as ultrasound equipment) performs. Apps that could transform smartphones or tablets into regulated medical devices (such as a blood glucose meter) could also qualify for FDA oversight.

An app that allows a doctor to view a medical image on an iPhone would also fall under the proposed guidelines as would one that turns an iPad into an EKG device to determine if a patient is having a heart attack.

Mobile apps that would not come under the guidelines include applications that would allow a physician to view a medical video or an application that could automate general office operations.

The healthcare community, especially hospitals and physicians, has been waiting for the FDA to reveal its plans to oversee the fast-growing mobile medical apps industry.

"The use of mobile medical apps on smartphones and tablets is revolutionizing healthcare delivery," said Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health in a statement. "Our draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don't work as intended."

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.

  • Must comply with the quality system regulation to help ensure that products consistently meet applicable requirements and specifications.
  • Must develop requirements for their products that will result in devices that are safe and effective, and to establish methods and procedures to design, produce, and distribute their devices.
  • Must comply with adverse event reporting requirements.
  • Must correct problems voluntarily or at the request of the FDA.

The FDA is accepting comments on the 30-page proposed guidelines for 90 days.

Margaret Dick Tocknell is a reporter/editor with HealthLeaders Media.
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