{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule amending requirements for medical device premarket submissions to remove paper and multiple copies and replace them with requirements for a single submission in electronic format. This action would reduce the number of copies in electronic format required, thus improving and making more efficient the FDA's premarket submission program for medical 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/2019/12/16/2019-27047.html","cfr_references":[{"chapter":null,"citation_url":null,"part":807,"title":21},{"chapter":null,"citation_url":null,"part":812,"title":21},{"chapter":null,"citation_url":null,"part":814,"title":21}],"citation":"84 FR 68334","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective January 15, 2020.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-N-0628"],"dockets":[],"document_number":"2019-27047","effective_on":"2020-01-15","end_page":68340,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2019/12/16/2019-27047.xml","html_url":"https://www.federalregister.gov/documents/2019/12/16/2019-27047/medical-device-submissions-amending-premarket-regulations-that-require-multiple-copies-and-specify","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2019-27047?publication_date=2019-12-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2019-12-16/2019-27047/mods.xml","not_received_for_publication":null,"page_length":7,"page_views":{"count":10762,"last_updated":"2026-07-27 18:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2019-12-16/pdf/2019-27047.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-27047.pdf?1576244726","publication_date":"2019-12-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2019/12/16/2019-27047.txt","regulation_id_number_info":{"0910-AH48":{"issue":"201910","html_url":"https://www.federalregister.gov/regulations/0910-AH48/amending-premarket-regulations-that-require-multiple-copies-and-specify-paper-copies-to-be-required-","title":"Amending Premarket Regulations That Require Multiple Copies and Specify Paper Copies to be Required in Electronic Format ","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201910&RIN=0910-AH48&operation=OPERATION_EXPORT_XML","priority_category":"Substantive, Nonsignificant"}},"regulation_id_numbers":["0910-AH48"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"07- Final Rule Reference Full FRIA 508","document_id":"FDA-2018-N-0628-0025"},{"title":"06 - Final Rule Reference 3 Least Burdensome Provisions","document_id":"FDA-2018-N-0628-0024"},{"title":"05 - Final Rule Reference 2 About Electronic Submission Gateway","document_id":"FDA-2018-N-0628-0023"},{"title":"04 - Final Rule Reference 1 eCopy Final Guidance","document_id":"FDA-2018-N-0628-0022"},{"title":"03 - eCopy Proposed Rule Regulatory Impact Analysis","document_id":"FDA-2018-N-0628-0004"},{"title":"02 - Reference 2-Electronic Submissions Gateway","document_id":"FDA-2018-N-0628-0003"},{"title":"01 - Reference 1-Guidance for eCopy Program for Medical Device Submissions","document_id":"FDA-2018-N-0628-0002"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2018-N-0628","supporting_documents_count":7,"docket_id":"FDA-2018-N-0628","regulation_id_number":null,"title":"Medical Device Submissions: Amending Premarket Regulations that Require Multiple Copies and Specify Paper Copies to be Allowed in Electronic Format; Companion to Direct Final Rule.","checked_regulationsdotgov_at":"2019-12-18T04:30:09Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":68334,"subtype":null,"title":"Medical Device Submissions: Amending Premarket Regulations That Require Multiple Copies and Specify Paper Copies To Be Required in Electronic Format","toc_doc":"Amending Premarket Regulations That Require Multiple Copies and Specify Paper Copies To Be Required in Electronic Format","toc_subject":"Medical Device Submissions:\n","topics":["Administrative practice and procedure","Confidential business information","Health records","Imports","Medical devices","Medical research","Reporting and recordkeeping requirements"],"type":"Rule","volume":84}