Letter to the FDA Criticizing the Agency’s Response to Public Citizen’s Report on Implanted Spinal Cord Stimulators for Pain Relief
Public Citizen expressed great disappointment regarding the Food and Drug Administration’s (FDA’s) recent letter reacting to the organization’s June 10, 2020, report, Implanted Spinal Cord Stimulators for Pain Relief: Illustrating the FDA’s Dangerously Lax Oversight of High-Risk Implantable Medical Devices. The terse non-responsive letter from the FDA was utterly dismissive about the detailed observations, concerns, and recommendations presented in the report and lacked any hint of thoughtful introspection about weaknesses in the agency’s oversight of high-risk implantable medical devices and the potential opportunities to address those weaknesses to better protect patients treated with these devices.
August 31, 2020, FDA response letter.
See Public Citizen’s June 10, 2020, report.
See Public Citizen’s other work on medical devices.