FDA Approval for Spinal Cord Stimulation in Diabetic Neuropathy

Historical Context of SCS Regulation

• The FDA asserted authority over implantable medical devices in 1976, and during the 1980s reviewed neurostimulation devices, according to the Journal of Neurosurgery 1, 2, 3
• The FDA ruled that spinal cord and peripheral nerve stimulation devices could continue to be marketed in the US without formal clinical trials of efficacy based on available publications and expert testimony for general chronic pain indications 1, 2

Current FDA-Approved Options

• The FDA has approved only three medications specifically for painful diabetic neuropathy: duloxetine, pregabalin, and tapentadol extended release, as stated by Diabetes Care 4, 5