EEG device 510(k)s need clinical data for most diagnostic claims -- FDA draft guidance.
This article was originally published in The Gray Sheet
Executive Summary
EEG DEVICE 510(k)s NEED CLINICAL DATA FOR DIAGNOSTIC CLAIMS OTHER THAN EPILEPSY, FDA says in a draft guidance on 510(k)s for electroencephalograph devices. Noting that the only diagnostic EEG claim that has been cleared via 510(k) is "aiding the physician in diagnosing epilepsy," FDA says that "any other intended use, including diagnostic claims that the manufacturer makes about the device's capabilities, should be supported by clinical data." Comments on the guidance are due by Jan. 2.
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