{"abstract":"The Food and Drug Administration (FDA) is amending the medical device tracking regulation. FDA is making substantive changes to revise the scope of the regulation and add certain patient confidentiality requirements, and nonsubstantive changes to remove outdated references and simplify terminology. These revisions are made to conform the regulation to changes made in section 519(e) of the Federal Food, Drug, and Cosmetic Act (the act) by the FDA Modernization Act of 1997 (FDAMA), and to simplify certain 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/2002/02/08/02-3076.html","cfr_references":[{"chapter":null,"citation_url":null,"part":821,"title":21}],"citation":"67 FR 5943","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective May 9, 2002. The information collection provisions of this final rule have been submitted to the Office of Management and Budget (OMB) for review. Prior to the effective date of this final rule, FDA will publish in the Federal Register a notice announcing OMB's decision to approve, modify, or disapprove the information collection provisions in this final rule.","disposition_notes":null,"docket_ids":["Docket No. 00N-1034"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":1,"comment_start_date":"2002-02-08","updated_at":"2024-11-14T13:02:19.923-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2000-N-0013-0001","allow_late_comments":false,"id":"FDA-2000-N-0013-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2000-N-0013","title":"Cost Assessment of Medical Device Tracking"}],"document_number":"02-3076","effective_on":"2002-05-09","end_page":5952,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2002/02/08/02-3076.xml","html_url":"https://www.federalregister.gov/documents/2002/02/08/02-3076/medical-devices-device-tracking","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/02-3076?publication_date=2002-02-08","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2002-02-08/02-3076/mods.xml","not_received_for_publication":null,"page_length":10,"page_views":{"count":1231,"last_updated":"2026-07-27 14:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2002-02-08/pdf/02-3076.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2002-02-08","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2002/02/08/02-3076.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":1,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2000-N-0013","supporting_documents_count":0,"docket_id":"FDA-2000-N-0013","document_id":"FDA-2000-N-0013-0001","regulation_id_number":null,"title":"Cost Assessment of Medical Device Tracking","checked_regulationsdotgov_at":"2025-06-05T22:55:06Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":5943,"subtype":null,"title":"Medical Devices; Device Tracking","toc_doc":"Device tracking","toc_subject":"Medical devices:","topics":["Imports","Medical devices","Reporting and recordkeeping requirements"],"type":"Rule","volume":67}