Glycemic Control Medical Device Guidance

FDA has published a draft guidance, Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus, with study recommendations for these devices. The document says that while several legally marketed medical devices help patients manage Type 2 diabetes, there are no legally marketed devices that are intended to therapeutically improve glycemic control in patients with Type 2 diabetes.

The contents of the guidance are Introduction, Background, Scope, Clinical Study Recommendations—Purpose/Objective, Study Design and Sample Size, Study Duration and Follow-Up Schedule, Inclusion/Exclusion Criteria, Patient Demographics, Treatment Parameters/Protocol (including post-operative regimen), Safety Endpoints and Data, Effectiveness Endpoints and Data, and Statistical Analysis Considerations.