{"abstract":"The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of product development protocol (PDP) for 41 class III medical devices. The agency has summarized its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements and the benefits to the public from the use of the devices.","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/1996/09/27/96-24753.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"868","title":21},{"chapter":null,"citation_url":null,"part":"870","title":21},{"chapter":null,"citation_url":null,"part":"872","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":"884","title":21},{"chapter":null,"citation_url":null,"part":"888","title":21},{"chapter":null,"citation_url":null,"part":"890","title":21}],"citation":"61 FR 50704","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"September 27, 1996.","disposition_notes":null,"docket_ids":["Docket No. 95N-0084"],"dockets":[],"document_number":"96-24753","effective_on":"1996-09-27","end_page":50711,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":null,"html_url":"https://www.federalregister.gov/documents/1996/09/27/96-24753/medical-devices-effective-date-of-requirement-for-premarket-approval-for-class-iii-preamendments","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/96-24753?publication_date=1996-09-27","mods_url":"https://www.govinfo.gov/metadata/granule/FR-1996-09-27/96-24753/mods.xml","not_received_for_publication":null,"page_length":8,"page_views":{"count":95,"last_updated":"2026-07-26 08:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-1996-09-27/pdf/96-24753.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"1996-09-27","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/1996/09/27/96-24753.txt","regulation_id_number_info":{"0910-AA31":{"issue":"199604","html_url":"https://www.federalregister.gov/regulations/0910-AA31/effective-date-of-requirement-for-submission-of-premarket-approval-applications","title":"Effective Date of Requirement for Submission of Premarket Approval Applications","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=199604&RIN=0910-AA31&operation=OPERATION_EXPORT_XML","priority_category":"Substantive, Nonsignificant"}},"regulation_id_numbers":["0910-AA31"],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-09-21T09:29:24Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":50704,"subtype":null,"title":"Medical Devices; Effective Date of Requirement for Premarket Approval for Class III Preamendments Devices","toc_doc":null,"toc_subject":null,"topics":[],"type":"Rule","volume":61}