Sunday, June 26, 2011

FDA Issues Draft Document

FDA issued a draft document to help advance the development and approval of an artificial pancreas system to treat Type 1 diabetes in the U.S. An artificial pancreas system is an automated, closed-loop system that combines a continuous glucose monitor, an insulin infusion pump, and a glucose meter for calibrating the monitor.

The draft document published on June 20, 2011 addresses an early version of an artificial pancreas system known as a Low Glucose Suspend (LGS) system which can help reduce or lessen the severity of a dangerous drop in glucose levels by temporarily reducing or stopping the delivery of insulin.

The release of the draft document clarifies information for manufacturers, investigators, and reviewers involved in developing an artificial pancreas system. The document provides information on how to submit an application for the LGS system intended for single patient use in the home environment. The document discusses safety and effectiveness goals that the FDA may require researchers and industry to meet when developing the LGS system.

FDA seeks input from industry, researchers, the clinical community, and other stakeholders on the draft document. Specifically, FDA is interested in the types of clinical studies that should be conducted and what the target outcomes should be to demonstrate safety and effectiveness. Comments and suggestions are due 90 days after the publication of the June 21st notice in the Federal Register.

FDA is working on a second draft guidance that will help manufacturers and researchers develop more autonomous artificial pancreas systems and this guidance document is expected to be issued by the end of the year.

To view the document “Draft Guidance for Industry and the FDA Staff: The Content of Investigational Device Exemption and Premarket Approval Application for Low Glucose Suspend Device Systems” go to