{"abstract":"The Food and Drug Administration (FDA) is classifying hemoglobin A1c test system into class II (special controls). The special controls that will apply to this device are identified in this order and will be part of the codified language for the hemoglobin A1c test system classification. 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/2014/08/25/2014-20022.html","cfr_references":[{"chapter":null,"citation_url":null,"part":862,"title":21}],"citation":"79 FR 50549","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective September 24, 2014. The classification was applicable May 23, 2013.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-N-1112"],"dockets":[],"document_number":"2014-20022","effective_on":"2014-09-24","end_page":50551,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/08/25/2014-20022.xml","html_url":"https://www.federalregister.gov/documents/2014/08/25/2014-20022/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-hemoglobin-a1c","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-20022?publication_date=2014-08-25","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-08-25/2014-20022/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":698,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-08-25/pdf/2014-20022.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-20022.pdf?1408711796","publication_date":"2014-08-25","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/08/25/2014-20022.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-2014-N-1112","supporting_documents_count":0,"docket_id":"FDA-2014-N-1112","regulation_id_number":null,"title":"Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of Hemoglobin A1c Test System","checked_regulationsdotgov_at":"2014-09-14T06:00:11Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":50549,"subtype":null,"title":"Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of Hemoglobin A1c Test System","toc_doc":"Clinical Chemistry and Clinical Toxicology Devices; Hemoglobin A1c Test System; Classification","toc_subject":"Medical Devices:","topics":["Medical devices"],"type":"Rule","volume":79}