FDA (Food and Drug Adminstration)
U.S. Food & Drug Administration Webpage-Contains information for consumers, health professionals, and researchers on food, drugs, medical devices, cosmetics, radiation emitting products, clinical trials, vaccines and biologics, and tobacco products.
- FDA Blood Glucose Monitoring Devices Webpage-Provides an overview of how devices work, safety tips and alerts and links to trending news on new devices and approvals.
- FDA Medical Device Approvals Search Page-Provides information on medical devices approved by the FDA. Click on the year to see approvals by year. For searches regarding Insulin pumps and CGM Hybrid Closed Loop Systems, Look for Glucose Monitoring under the Category Heading. Each product labeling will indicate which pump and CGM unit are approved for combination use.
- Note: In May 2019 the FDA issued a warning alert about safety issues of non-FDA approved devices titled: FDA Safety Communication: Devices for Diabetes Management May, 2019.
MedWatch: The FDA Safety Information and Adverse Reporting Program- Provides information on labeling changes, drug prescribing information, medication Guides, safety Information from the FDA Adverse Event Reporting System (FAERS), current Drug Shortages Index, recalled products, and an FDA Guide to Drug Safety Terms (FDA, 3/26/18).
Page Updated 8/27/19