The U.S. Food and Drug Administration issued draft guidance yesterday aimed at advancing the approval of artificial pancreas systems for treatment of type 1 diabetes.
The document addressed premarket approval and investigational device exemption for low glucose suspend devices, artificial pancreas systems that help reduce the severity of a drop in glucose levels by automatically adjusting insulin flow.
The system combines a continuous glucose monitor, an insulin infusion pump and a glucose meter. The artificial pancreas monitors glucose levels and automatically adjusts insulin doses, but still requires that patients keep an eye on their blood sugar and supplement themselves with an insulin injection when necessary.
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The FDA asked for suggestions from industry, researchers and physicians, especially with regard to the types of clinical studies that should be conducted and standards for safety and efficacy, according to the document.
The FDA released a second guidance yesterday, covering ergonomic engineering and testing for medical devices “intended to improve the usability of devices to reduce use error, injuries from medical devices, and product recalls,” including device-specific and general recommendations.
The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
