{"abstract":"The Food and Drug Administration (FDA) is classifying the neuropsychiatric interpretive electroencephalograph (EEG) assessment aid into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.","action":"Final order.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2014/02/18/2014-03388.html","cfr_references":[{"chapter":null,"citation_url":null,"part":882,"title":21}],"citation":"79 FR 9083","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective March 20, 2014. The classification was applicable beginning July 15, 2013.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-M-0042"],"dockets":[],"document_number":"2014-03388","effective_on":"2014-03-20","end_page":9085,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/02/18/2014-03388.xml","html_url":"https://www.federalregister.gov/documents/2014/02/18/2014-03388/medical-devices-neurological-devices-classification-of-the-neuropsychiatric-interpretive","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-03388?publication_date=2014-02-18","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-02-18/2014-03388/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":773,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-02-18/pdf/2014-03388.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-03388.pdf?1392385761","publication_date":"2014-02-18","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/02/18/2014-03388.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2013-M-0042","supporting_documents_count":0,"docket_id":"FDA-2013-M-0042","regulation_id_number":null,"title":"Classification of the Ingestible Event Marker","checked_regulationsdotgov_at":"2014-03-10T06:00:10Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":9083,"subtype":null,"title":"Medical Devices; Neurological Devices; Classification of the Neuropsychiatric Interpretive Electroencephalograph Assessment Aid","toc_doc":"Classification of the Neuropsychiatric Interpretive Electroencephalograph Assessment Aid","toc_subject":"Medical Devices; Neurological Devices:","topics":["Medical devices"],"type":"Rule","volume":79}