FDA Guidance on Blood Glucose Monitors
- Food and Drug Administration
- All Healthcare Organizations
The U.S. Food and Drug Administration (FDA) has issued two revised draft guidances regarding the use of point-of-care blood glucose monitors in health care and home settings. The new draft guidances are:
- Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use and,
- Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use.
When finalized, these draft guidances will update guidances last issued in 2016 and will:
- Provide more clarification on design considerations …