Home » FDA Offers Guidance for Sponsors of Noninsulin Control Devices for Type 2 Diabetes
FDA Offers Guidance for Sponsors of Noninsulin Control Devices for Type 2 Diabetes
Devices Regulatory Affairs
Developers of new devices that improve glycemic control in patients with type 2 diabetes should submit a pre-submission to the agency to get detailed feedback on the design of feasibility studies, the FDA said in a new guidance.
Noninsulin control devices include neurostimulators and devices that mimic surgical procedures, such as bariatric surgery, that alter the anatomy or physiology of the small intestines or manipulate the sympathetic nervous system.
Although there are devices on the market that help patients manage type 2 diabetes, such as glucose monitors and insulin pens, there are currently no cleared devices designed to improve glycemic control in patients with type 2 diabetes.