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FDA Issues Draft Guidance for Early Version of an Artificial Pancreas System
Date:6/20/2011

ut from industry, researchers, the clinical community, and other stakeholders on the draft Low Glucose Suspend guidance. Specifically, the agency is interested in the types of clinical studies that should be conducted and what their target outcomes should be to demonstrate safety and effectiveness, necessary requirements for FDA approval.

"Our goal is to provide a clear pathway for artificial pancreas development so that people with diabetes can benefit from innovative medical devices," said Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health. "Getting a safe and effective artificial pancreas system to Americans with type 1 diabetes is an FDA priority."

The FDA currently is working on a second draft guidance that will help manufacturers and researchers develop more autonomous artificial pancreas systems. That guidance is expected to be issued by the end of the year.

For more information:

Draft Guidance http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm259301.htm

FDA: Artificial Pancreas Systems

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/ArtificialPancreas/default.htm

FDA: Medical Devices

http://www.fda.gov/MedicalDevices/default.htm

CDC:  Centers for Disease Control and Prevention—Diabetes Public Health Resource

http://www.cdc.gov/diabetes/

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 hu
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SOURCE U.S. Food and Drug Administration
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