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Risk Classification And The Device-Benefit Question: Cranial Electrotherapy Stimulators

This article was originally published in The Gray Sheet

Executive Summary

Companies are suspicious of FDA motivations in the drawn-out reclassification process for cranial electrotherapy stimulators. But the case also underscores how the agency's efforts to place devices in the appropriate risk category turns not only on the perceived safety of a device, but evidence supporting its benefits and the types of evidence the agency is comfortable accepting.

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