{"abstract":"The Food and Drug Administration (FDA) is amending its regulations that govern reports of corrections and removals of medical devices to eliminate the requirement for distributors to make such reports. The amendments are being made to implement provisions of the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDA is publishing these amendments in accordance with its direct final rule procedures. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule under FDA's usual procedures for notice and comment to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comment and withdraws the direct final rule.","action":"Direct 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/1998/08/07/98-21091.html","cfr_references":[{"chapter":null,"citation_url":null,"part":806,"title":21}],"citation":"63 FR 42229","comment_url":null,"comments_close_on":"1998-10-21","correction_of":null,"corrections":[],"dates":"The regulation is effective December 21, 1998. Submit written comments on or before October 21, 1998. Submit written comments on the information collection provisions on or before October 6, 1998. If FDA receives no significant adverse comment within the specified comment period, the agency intends to publish a document confirming the effective date of the final rule in the Federal Register within 30 days after the comment period on this direct final rule ends.","disposition_notes":null,"docket_ids":["Docket No. 98N-0439"],"dockets":[],"document_number":"98-21091","effective_on":"1998-12-21","end_page":42233,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":null,"html_url":"https://www.federalregister.gov/documents/1998/08/07/98-21091/medical-devices-reports-of-corrections-and-removals","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/98-21091?publication_date=1998-08-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-1998-08-07/98-21091/mods.xml","not_received_for_publication":null,"page_length":5,"page_views":{"count":366,"last_updated":"2026-04-05 02:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-1998-08-07/pdf/98-21091.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"1998-08-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/1998/08/07/98-21091.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-09-21T08:14:22Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":42229,"subtype":null,"title":"Medical Devices; Reports of Corrections and Removals","toc_doc":null,"toc_subject":null,"topics":[],"type":"Rule","volume":63}