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FDA Outlines Oversight of Mobile Medical Applications
Date:7/19/2011

y using attachments, sensors or other devices
(For example, an application that turns a smartphone into an ECG machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack).

The agency is seeking public input on this approach. Once posted, comments can be submitted for 90 days online or in writing to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD  20852. The FDA will update the guidance based on feedback received.

For more information:
FDA: Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Applications:
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, 301-796-4988, erica.jefferson@fda.hhs.gov
Amanda Sena, 301-796-0393, amanda.sena@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA


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SOURCE U.S. Food and Drug Administration
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