FDA Outlines Plan for Artificial Pancreas Approval

The U.S. Food and Drug Administration today issued guidance for scientists and device manufacturers seeking approval for the artificial pancreas – a portable device to help people with type 1 diabetes control their blood sugar levels. The draft guidance offers design and testing recommendations aimed at easing the approval process while still meeting statutory requirements for safety and effectiveness. It comes less than a month after lawmakers, health professionals, advocacy organizations and...Full Story
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