Report: Implanted Spinal Cord Stimulators for Pain Relief – Illustrating the FDA’s Dangerously Lax Oversight of High-Risk Implantable Medical Devices
View cover letter to the FDA as PDF
View cover letter to U.S. House of Representatives’ Energy & Commerce Committee as PDF
View cover letter to the U.S. Senate’s Committee on Health, Education, Labor & Pensions as PDF
In a report delivered to the Commissioner of the Food and Drug Administration (FDA) and key congressional committees, Public Citizen documented the FDA’s dangerously lax regulatory oversight of high-risk implanted spinal cord stimulators for pain relief, which has resulted in unnecessary harm to patients. The FDA’s regulatory oversight of implanted spinal cord stimulators for pain relief has had serious, wide-ranging deficiencies for several decades and is emblematic of what’s wrong with the agency’s oversight of medical devices.
June 25, 2020, FDA response letter.
See Public Citizen’s other work on medical devices.