FDA Panel Sets Meeting Date to Discuss CES Reclassification

The Neurological Devices Panel of the US Food and Drug Administration’s Medical Devices Advisory Committee will hold a public meeting on February 10, 2012 to consider requiring premarket approvals for cranial electrotherapy stimulators (CES).

Although currently classified as Class III devices, CES products are allowed to go through the 510(k) premarket notification process in order to be sold in the US market. The agency first proposed the more stringent premarket approval pathway for CES devices in August 2011. Prior to the meeting, the FDA will make available reclassification petitions that have been filed in response to its proposed rule, as well as other pertinent background material.

The meeting will examine existing data supporting CES safety and effectiveness, as well as whether that data is robust enough to support classification of these devices under Class II. Individuals and organizations interested in attending may submit written materials by February 6, 2012; those interested in making oral presentations at the meeting should notify the agency by January 27, 2012.

The FDA’s contact person for the meeting is Avena Russell; she may be reached via email at avena.russell@fda.hhs.gov

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