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FDA Proposes New Policy for Some Diagnostic and Radiology Devices
Date:7/7/2011

atient communities. The draft guidance is open for comment for 90 days.

In the future, the FDA also intends to reduce the pre-market regulatory burden on additional in vitro diagnostic and radiology device types.

For more information:

FDA:  Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm262071.htm

FDA: Medical Devices
http://www.fda.gov/MedicalDevices/default.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
Consumer Inquiries: 888-INFO-FDA


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SOURCE U.S. Food and Drug Administration
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