{"abstract":"The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis. The agency is summarizing its proposed findings regarding the degree of risk of illness or injury intended to be eliminated or reduced by requiring the device to meet the statute's approval requirements as well as the benefits to the public from the use of the device. The agency also is proposing to revise the name and identification of the device. In addition, FDA is announcing the opportunity for interested persons to request the agency to change the classification of the device based on new information. FDA is taking this action under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).","action":"Proposed rule; opportunity to request a change in classification.","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/2004/03/05/04-4885.html","cfr_references":[{"chapter":null,"citation_url":null,"part":888,"title":21}],"citation":"69 FR 10390","comment_url":null,"comments_close_on":"2004-06-03","correction_of":null,"corrections":[],"dates":"Submit written or electronic comments by June 3, 2004; submit written or electronic requests for a change in classification by March 22, 2004.","disposition_notes":null,"docket_ids":["Docket No. 2003N-0561"],"dockets":[],"document_number":"04-4885","effective_on":null,"end_page":10397,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2004/03/05/04-4885.xml","html_url":"https://www.federalregister.gov/documents/2004/03/05/04-4885/orthopedic-devices-effective-date-of-the-proposed-requirement-for-premarket-approval-of-the-hip","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/04-4885?publication_date=2004-03-05","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2004-03-05/04-4885/mods.xml","not_received_for_publication":null,"page_length":8,"page_views":{"count":97,"last_updated":"2026-10-23 20:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2004-03-05/pdf/04-4885.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2004-03-05","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2004/03/05/04-4885.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-11-12T10:52:36Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":10390,"subtype":null,"title":"Orthopedic Devices; Effective Date of the Proposed Requirement for Premarket Approval of the Hip Joint Metal/Polymer or Ceramic/Polymer Semiconstrained Resurfacing Cemented Prosthesis","toc_doc":"Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis; premarket approval requirement effective date","toc_subject":"Medical devices:","topics":["Medical devices"],"type":"Proposed Rule","volume":69}