{"abstract":"The Food and Drug Administration (FDA) is codifying the exemption from premarket notification of all 62 class II (special controls) devices listed as exempt in a January 21, 1998, Federal Register notice, subject to the limitations on exemptions. FDA has determined that for these exempted devices, manufacturers' submissions of premarket notifications are unnecessary to provide a reasonable assurance of safety and effectiveness. These devices will remain subject to current good manufacturing practice (CGMP) regulations and other general controls. This rulemaking implements new authorities delegated to FDA under the Food and Drug Administration Modernization Act (FDAMA). EFFECTIVE DATE: November 3, 1998.","action":"Final 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/1998/11/03/98-29189.html","cfr_references":[{"chapter":null,"citation_url":null,"part":862,"title":21},{"chapter":null,"citation_url":null,"part":864,"title":21},{"chapter":null,"citation_url":null,"part":866,"title":21},{"chapter":null,"citation_url":null,"part":876,"title":21},{"chapter":null,"citation_url":null,"part":880,"title":21},{"chapter":null,"citation_url":null,"part":882,"title":21},{"chapter":null,"citation_url":null,"part":886,"title":21},{"chapter":null,"citation_url":null,"part":890,"title":21},{"chapter":null,"citation_url":null,"part":892,"title":21}],"citation":"63 FR 59222","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"November 3, 1998.","disposition_notes":null,"docket_ids":["Docket No. 98-0015"],"dockets":[],"document_number":"98-29189","effective_on":"1998-11-03","end_page":59231,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":null,"html_url":"https://www.federalregister.gov/documents/1998/11/03/98-29189/medical-devices-exemptions-from-premarket-notification-class-ii-devices","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/98-29189?publication_date=1998-11-03","mods_url":"https://www.govinfo.gov/metadata/granule/FR-1998-11-03/98-29189/mods.xml","not_received_for_publication":null,"page_length":10,"page_views":{"count":428,"last_updated":"2026-07-25 22:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-1998-11-03/pdf/98-29189.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"1998-11-03","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/1998/11/03/98-29189.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-09-21T12:13:13Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":59222,"subtype":null,"title":"Medical Devices; Exemptions From Premarket Notification; Class II Devices","toc_doc":null,"toc_subject":null,"topics":[],"type":"Rule","volume":63}