{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled \"Implementation of Medical Device Establishment Registration and Device Listing Requirements Established by the Food and Drug Administration Amendments Act of 2007.\" The purpose of this guidance is to explain recent changes in the device registration and listing program to owner/operators and official correspondents of device establishments and to help them fulfill these new requirements. The guidance also describes the information that owner/operators of device establishments must submit to register their establishments and list their devices electronically, using FDA Form No. 3673. Those owner/operators seeking a waiver from the electronic submission requirement must submit their requests in writing to FDA with a complete explanation of why their registration and listing information cannot reasonably be submitted electronically. This guidance document is immediately in effect, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).","action":"Notice.","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/2009/10/08/E9-24349.html","cfr_references":[],"citation":"74 FR 51864","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit written or electronic comments on this guidance at any time. General comments on agency guidelines are welcome at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2009-D-0438"],"dockets":[],"document_number":"E9-24349","effective_on":null,"end_page":51865,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2009/10/08/E9-24349.xml","html_url":"https://www.federalregister.gov/documents/2009/10/08/E9-24349/guidance-for-industry-and-food-and-drug-administration-staff-implementation-of-medical-device","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/E9-24349?publication_date=2009-10-08","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2009-10-08/E9-24349/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":62,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2009-10-08/pdf/E9-24349.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2009-10-08","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2009/10/08/E9-24349.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2010-07-19T14:31:15Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":51864,"subtype":null,"title":"Guidance for Industry and Food and Drug Administration Staff; Implementation of Medical Device Establishment Registration and Device Listing Requirements Established by the Food and Drug Administration Amendments Act of 2007; Availability","toc_doc":"Implementation of Medical Device Establishment Registration, etc.","toc_subject":"Guidance for Industry and Food and Drug Administration Staff; Availability:","topics":[],"type":"Notice","volume":74}