Regulatory News In Brief

FDA released its final guidance Nov. 9 on investigational device exemption and pre-market approval applications for artificial pancreas device systems. The document finalizes two draft guidances – a December 2011 proposal on clinical trial designs for artificial pancreas systems and a June 2011 draft on IDEs and PMAs for low glucose suspend systems. (See Also see "FDA Releases Draft Guidance On Closed-Loop Artificial Pancreas Devices" - Medtech Insight, 5 December, 2011. and Also see "Diabetes Researchers Say FDA Is Slowing Artificial Pancreas Efforts" - Medtech Insight, 27 June, 2011..) The final guidance provides recommendations to sponsors planning IDEs or PMAs for artificial pancreas systems, including low glucose suspend systems, for home use. The guidance aims to allow “sufficient flexibility” to accommodate the different clinical trial routes sponsors want to take, FDA notes. More in-depth coverage on the guidance will appear in “The Gray Sheet” next week.

CDRH’s Office of Compliance plans to submit a reorganization proposal that would include the creation of three new divisions: a Division of International Compliance Operations, a Division of Pre-market and...