{"abstract":"The Food and Drug Administration is proposing to amend its regulations governing medical device establishment registration and device listing. The proposed revisions would modify FDA's current regulations at part 807 (21 CFR part 807) to reflect recent statutory amendments to the device registration and listing provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Food and Drug Administration Amendments Act of 2007 (FDAAA), which was enacted on September 27, 2007, amended section 510 of the FD&C Act by requiring domestic and foreign device establishments to begin submitting their registration and device listing information to FDA by electronic means rather than on paper forms, and also specified the timeframes when establishments are required to submit such information. In accordance with FDAAA, the agency launched FDA's Unified Registration and Listing System (FURLS), and Internet-based registration and listing system. FDAAA requires electronic submission of device registration and listing information unless FDA grants a waiver request. In addition, this proposal would facilitate FDA's collection of additional registration information from foreign establishments as required by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act). It also would update certain provisions in part 807 to improve the quality of registration and listing information available to FDA. FDA relies on having complete and accurate registration and listing information in order to accomplish a number of important public health objectives.","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/2010/03/26/2010-6662.html","cfr_references":[{"chapter":null,"citation_url":null,"part":807,"title":21}],"citation":"75 FR 14510","comment_url":null,"comments_close_on":"2010-06-24","correction_of":null,"corrections":[],"dates":"Submit written or electronic comments on the proposed rule by June 24, 2010. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by April 26, 2010, (see the \"Paperwork Reduction Act of 1995\" section of this document). See sections IX and X of this document for the proposed effective and proposed compliance dates of a final rule based on this document.","disposition_notes":null,"docket_ids":["Docket No. FDA-2009-N-0114"],"dockets":[],"document_number":"2010-6662","effective_on":null,"end_page":14538,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2010/03/26/2010-6662.xml","html_url":"https://www.federalregister.gov/documents/2010/03/26/2010-6662/implementation-of-device-registration-and-listing-requirements-enacted-in-the-public-health-security","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2010-6662?publication_date=2010-03-26","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2010-03-26/2010-6662/mods.xml","not_received_for_publication":null,"page_length":29,"page_views":{"count":1704,"last_updated":"2026-04-04 10:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2010-03-26/pdf/2010-6662.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2010-03-26","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2010/03/26/2010-6662.txt","regulation_id_number_info":{"0910-AF88":{"issue":"201110","html_url":"https://www.federalregister.gov/regulations/0910-AF88/electronic-registration-and-listing-for-devices","title":"Electronic Registration and Listing for Devices","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201110&RIN=0910-AF88&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AF88"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Tab B - \"Changes in the Regulatory Action - [OMB Review, EO12866, RPMS Note to the DDM, May 5, 2010 - (Implementation of Device Registration and Listing Requirements Enacted in Section 321 of the Public Health Security and Bioterrorism Preparedness and Re","document_id":"FDA-2009-N-0114-0004"},{"title":"Tab A - \"Draft Regulatory Action , May 5, 2010\" - [OMB Review, EO12866, RPMS Note to the DDM, May 5, 2010 - (Implementation of Device Registration and Listing Requirements Enacted in Section 321 of the Public Health Security and Bioterrorism Preparedness ","document_id":"FDA-2009-N-0114-0003"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2009-N-0114","supporting_documents_count":2,"docket_id":"FDA-2009-N-0114","regulation_id_number":null,"title":"Implementation of Device Registration and Listing Requirements Enacted in Section 321 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act), Section 207 of the Medical Device User Fee and Modernization Act","checked_regulationsdotgov_at":"2010-03-26T16:11:04Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":14510,"subtype":null,"title":"Implementation of Device Registration and Listing Requirements Enacted in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the Medical Device User Fee and Modernization Act of 2002, and Title II of the Food and Drug Administration Amendments Act of 2007","toc_doc":"Implementation of Device Registration and Listing Requirements; Public Health Security and Bioterrorism Preparedness and Response Act, etc.","toc_subject":null,"topics":[],"type":"Proposed Rule","volume":75}