FDA Oversight of High Risk Devices: A Focus on Neurosurgery

Introduction: As one of the most rigorous examinations for medical devices, FDA Premarket Approval is seen as the global standard for device approval. In the wake of increasing research in machine learning and brain-computer interfaces (BCIs), more pressure has been mounting on FDA to maintain high standards of safety without compromising medical innovation. To triage products into approval pathways, FDA assigns each product a risk classification which determines the amount of testing a device requires before FDA approval. A product’s classification will determine whether its review will be streamlined, as lower risk devices are eligible for expedited approval, at 88 days compared to 181 for high risk [FDA, 2022]. Furthermore, low to medium risk devices can serve as predicates allowing similar future devices to undergo expedited review.

Methods: In this study, we examined the Devices@FDA database for approved neurological medical devices across all risk categories. We then examined the devices approved in the high risk category to look for trends in devices deemed high risk by the FDA.

Results: Since the Medical Device Amendments were passed in 1976, 208 neurological device classifications have been approved across three risk categories: 11 high risk, 161 medium risk, 35 low risk with 1 device granted humanitarian approval. Of the high risk devices, 5 out of the 11 devices were implantable and 7 met the definition of a neural stimulator and/or BCI.

Conclusion : To date, this is the only study examining all FDA approved neurosurgical product categories by risk. A high percentage of high risk stimulator and implantable devices could reflect bias towards these devices within the FDA approval process itself rather than real-world risk of these devices. A novel device should be independently assessed on its potential benefits and risk rather than FDA’s prior experiences. While it is hard to draw conclusions from this analysis alone, further research will allow neurosurgeons to gain a more fundamental understanding of how the FDA weighs device efficacy and safety to allow for more efficient innovation.

Source: FDA