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Medical Device Regulation

FDA Withdraws PMA Plan For Cranial Electrotherapy Stimulators

This article was originally published in The Gray Sheet

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Executive Summary

CDRH withdrew a prior proposal to require PMAs and class III risk-status for cranial electrotherapy stimulators, and now says it plans to downclassify the devices into class II, with special controls.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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