Regulatory oversights for implantable neurodevices

The deficiencies surrounding approvals, monitoring, and recall mechanisms are highlighted in a report from the International Consortium of Investigative Journalists.1 The report led to promises by the US Food and Drug Administration (FDA) and Canada's Ministry of Health to overhaul their regulatory systems.2,3 It underscored the limitations of the regulatory environment for medical devices, including an inadequate approval process, the scarcity of device registries, and a recall process that relies primarily on device manufacturers to notify regulatory agencies of adverse events. None of the implantable neurological devices in the IMDD is classified as class I, low-risk objects, such as bandages and tongue depressors. 131 (57%) of 229 implantable neurological devices listed in the IMDD are class II, intermediate risk devices, such as cerebrospinal fluid shunts, temporary aneurysm clips, and cranial bone flap fixation plates and screws. 91 (40%) implantable neurological devices are class III, high-risk devices, such as deep brain stimulation components and spinal cord stimulators. New class III neurological devices are subject to the FDA premarket approval process, which requires extensive testing to show the existence of “valid scientific evidence […] providing reasonable assurance that the device is safe and effective for its intended use”.5 Devices can also be approved using the alternative and substantially less burdensome 510(k) process.