{"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 a product development protocol (PDP) for pacemaker programmers. The Agency has summarized its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring this device to meet the statute's approval requirements and the benefits to the public from the use of the devices. This action implements certain statutory requirements.","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/2012/06/22/2012-15258.html","cfr_references":[{"chapter":null,"citation_url":null,"part":870,"title":21}],"citation":"77 FR 37570","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective September 20, 2012.","disposition_notes":null,"docket_ids":["Docket No. FDA-2011-N-0526"],"dockets":[],"document_number":"2012-15258","effective_on":"2012-09-20","end_page":37573,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2012/06/22/2012-15258.xml","html_url":"https://www.federalregister.gov/documents/2012/06/22/2012-15258/effective-date-of-requirement-for-premarket-approval-for-a-pacemaker-programmer","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2012-15258?publication_date=2012-06-22","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2012-06-22/2012-15258/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":245,"last_updated":"2026-07-26 10:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2012-06-22/pdf/2012-15258.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2012-15258.pdf?1340283702","publication_date":"2012-06-22","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2012/06/22/2012-15258.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-2011-N-0526","supporting_documents_count":0,"docket_id":"FDA-2011-N-0526","regulation_id_number":null,"title":"Effective Date of Requirement for Premarket Approval for a Pacemaker Programmer","checked_regulationsdotgov_at":"2012-07-12T08:03:48Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":37570,"subtype":null,"title":"Effective Date of Requirement for Premarket Approval for a Pacemaker Programmer","toc_doc":"Requirement for Premarket Approval for a Pacemaker Programmer; Effective Date","toc_subject":null,"topics":["Medical devices"],"type":"Rule","volume":77}