Zdrowie i gospodarka · 03/07/2007
Neurological Devices; Denial of Request for Change in Classification of Cutaneous Electrode
The Food and Drug Administration (FDA) is denying the petition submitted by Scientific Laboratory Products LTD., to reclassify electroencephalogram (EEG) electrodes from class II to class I. The agency is denying the petition because the Scientific Laboratory Products LTD., failed to provide sufficient new information to establish that general controls would provide reasonable assurance of the safety and effectiveness of the devices. This document also summarizes the basis for the agency's decision.