FDA's proactive role in the development of an artificial pancreas for the treatment of diabetes mellitus

Affiliations

• ¹ Center for Devices and Radiological Health, U.S. Food and Drug Administration, Office of Device Evaluation, 9200 Corporate Boulevard, HFZ-480, Rockville, MD 20850, United States. Electronic address:[email protected].
• ² National Institute of Diabetes, Digestive and Kidney Diseases, National Institutes of Health, Division of Diabetes, Endocrinology and Metabolic Diseases, 6707 Democracy Boulevard, Bethesda, MD 20892, United States.
• ³ National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, 6707 Democracy Boulevard, Bethesda, MD 20892, United States.
• ⁴ Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Division of Metabolism and Endocrinology Products, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, United States.
• ⁵ Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Office of Cellular, Tissue, and Gene Therapies, 1401 Rockville Pike, Rockville, MD 20852, United States.
• ⁶ Center for Devices and Radiological Health, U.S. Food and Drug Administration, Office of Device Evaluation, 9200 Corporate Boulevard, HFZ-480, Rockville, MD 20850, United States.