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FDA Outlines Oversight of Mobile Medical Applications

Agency seeking public input on its proposed approach

SILVER SPRING, Md. July 19, 2011

http://photos.prnewswire.com/prnh/20090824/FDALOGO

Today, mobile medical applications or "mobile medical apps," include a variety of functions, ranging from monitoring calorie intake, helping people maintain a healthy weight, and allowing doctors to view a patient’s radiology images on their mobile communications device. According to Research2Guidance 2010, 500 million smartphone users worldwide will be using a health care application by 2015.

Jeffrey Shuren

The agency’s draft guidance defines a small subset of mobile medical apps that impact or may impact the performance or functionality of currently regulated medical devices. This subset includes mobile medical apps that:

Rockville, MD

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm263280.htm

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Erica Jefferson [email protected]
Amanda Sena [email protected]
Consumer Inquiries:

SOURCE U.S. Food and Drug Administration

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