FDA ISSUES DRAFT GUIDANCE ON PORTABLE INVASIVE BLOOD GLUCOSE MONITORING SYSTEMS

The FDA issued draft guidance Oct. 24 on portable invasive blood glucose monitoring systems (BGMSs).

The guidance provides recommendations on preparing premarket notifications, or 510(k)s. It also discusses features of device design and risk management. BGMSs are regulated as Class II devices, the guidance says.

The document, "Draft Guidance for Industry and FDA Staff -- Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems," can be viewed at www.fda.gov/cdrh/oivd/guidance/1603.pdf (http://www.fda.gov/cdrh/oivd/guidance/1603.pdf).