{"abstract":"The Food and Drug Administration (FDA) is classifying the ingestible event marker 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/2013/05/16/2013-11628.html","cfr_references":[{"chapter":null,"citation_url":null,"part":880,"title":21}],"citation":"78 FR 28733","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective June 17, 2013. The classification was applicable beginning July 10, 2012.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-M-0042"],"dockets":[],"document_number":"2013-11628","effective_on":"2013-06-17","end_page":28735,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/05/16/2013-11628.xml","html_url":"https://www.federalregister.gov/documents/2013/05/16/2013-11628/medical-devices-general-hospital-and-personal-use-monitoring-devices-classification-of-the","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-11628?publication_date=2013-05-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-05-16/2013-11628/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":345,"last_updated":"2026-07-28 10:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-05-16/pdf/2013-11628.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-11628.pdf?1368623741","publication_date":"2013-05-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/05/16/2013-11628.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":"2013-06-05T08:04:44Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":28733,"subtype":null,"title":"Medical Devices; General Hospital and Personal Use Monitoring Devices; Classification of the Ingestible Event Marker","toc_doc":"General Hospital and Personal Use Monitoring Devices; Ingestible Event Marker Classification","toc_subject":"Medical Devices:","topics":["Medical devices"],"type":"Rule","volume":78}