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Regulatory device approval for stroke: fair and balanced?

Dr Pena et al provide a regulatory perspective on the Food and Drug Administration’s (FDA) device approval process.1 Reflecting the growing importance of the topic, this is the second such review and accompanying editorial comment to appear in Stroke ,2,3 the first being prompted by the FDA’s clearance of the MERCI retriever device.4 For those more familiar with the FDA’s requirements for the introduction of a new pharmaceutical, the differences in the regulatory approach for device approval are striking.

The FDA’s Premarket Notification 510(k) clearance process is the most frequently used and requires that a new device be substantially equivalent to a legally marketed predicate device (ie, the new device is substantially similar in design, function, and indication for use to one previously approved). The approval can be based entirely on preclinical data; no human testing is necessarily required. The assumption is that the new device represents an incremental change and does not compromise safety as compared with the older one. It might or might not have purported advantages as compared with a device or devices that are already in use for the same or similar purpose. Whether the new device is truly as safe or actually has the professed advantages does not need to be established through a comparative study. The analogy to a pharmaceutical might be a new drug for a specific indication that has a slightly altered chemical structure which is anticipated to increase its potency based on the results of studies conducted in tissue culture or in laboratory animals. In contrast to the situation for devices, such a drug would not achieve regulatory approval without adequate …