- The FDA's Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee meets today and tomorrow to review two applications for diabetes-related devices.
- Today, it will discuss Dexcom's (NASDAQ:DXCM) premarket approval application (PMA) panel-track supplement for a proposed change in the intended use of its Dexcom G5 Mobile Continuous Glucose Monitoring System (CGM) that will allow patients to use the device as a replacement for their blood glucose meters and make treatment decisions based on the glucose concentration in the interstitial fluid reported by the CGM.
- Tomorrow, the panel will discuss Alere's (NYSE:ALR) 510(k) submission seeking clearance of its Afinion HbA1c Dx point-of-care (POC) test system, an in vitro diagnostic test for the quantitative determination of glycated hemoglobin (% hemoglobin A1c) in human whole blood. Current clinical guidelines do not support POC hemoglobin tests to diagnose diabetes.
- FDA briefing doc - Dexcom
- Dexcom briefing doc
- FDA briefing doc - Alere
- FDA briefing doc appendices - Alere
- Alere briefing doc
- Panel questions - Alere