{"abstract":"The Food and Drug Administration (FDA) is proposing to amend the classification regulation for the electrocardiograph electrode device to establish special controls and to exempt the device from the premarket notification requirements of the Federal Food, Drug, and Cosmetic Act (the act). The agency is taking this action on its own initiative. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance document that would serve as the special control for the device if the rule is finalized. The agency believes that special controls, when followed and combined with the general controls, will provide reasonable assurance of the safety and effectiveness of these devices, if this proposal becomes final.","action":"Proposed rule.","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/2007/10/04/E7-19580.html","cfr_references":[{"chapter":null,"citation_url":null,"part":870,"title":21}],"citation":"72 FR 56702","comment_url":null,"comments_close_on":"2008-01-02","correction_of":null,"corrections":[],"dates":"Submit written or electronic comments by January 2, 2008. See section VI of this document for the proposed effective date of a final rule based on this proposed rule.","disposition_notes":null,"docket_ids":["Docket No. 2007N-0308"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":2,"comment_start_date":"2007-10-04","updated_at":"2025-08-08T01:56:06.221-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2007-N-0092-0001","allow_late_comments":false,"id":"FDA-2007-N-0092-0001","comment_end_date":"2008-01-03","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2007-N-0092","title":"Medical Devices; Cardiovascular Devices; Electrocardiograph Electrode; Designation of Special Controls"}],"document_number":"E7-19580","effective_on":null,"end_page":56704,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2007/10/04/E7-19580.xml","html_url":"https://www.federalregister.gov/documents/2007/10/04/E7-19580/medical-devices-cardiovascular-devices-electrocardiograph-electrode-designation-of-special-controls","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/E7-19580?publication_date=2007-10-04","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2007-10-04/E7-19580/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":43,"last_updated":"2026-04-03 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2007-10-04/pdf/E7-19580.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2007-10-04","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2007/10/04/E7-19580.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":2,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2007-N-0092","supporting_documents_count":0,"docket_id":"FDA-2007-N-0092","document_id":"FDA-2007-N-0092-0001","regulation_id_number":null,"title":"Medical Devices; Cardiovascular Devices; Electrocardiograph Electrode; Designation of Special Controls","checked_regulationsdotgov_at":"2025-08-09T08:55:03Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":56702,"subtype":null,"title":"Medical Devices; Cardiovascular Devices; Electrocardiograph Electrode; Designation of Special Controls","toc_doc":"Electrocardiograph electrode; special controls designation","toc_subject":"Medical devices:","topics":["Medical devices"],"type":"Proposed Rule","volume":72}