{"abstract":"The Food and Drug Administration (FDA) is issuing a final rule 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 also is summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements and the benefits to the public from the use of the devices. This action implements certain statutory 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/2004/10/04/04-22210.html","cfr_references":[{"chapter":null,"citation_url":null,"part":888,"title":21}],"citation":"69 FR 59132","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective October 4, 2004. Under this final rule, a PMA or a notice of completion of a PDP is required to be filed on or before January 3, 2005, for any hip joint metal/polymer or ceramic/ polymer semiconstrained resurfacing cemented prosthesis.","disposition_notes":null,"docket_ids":["Docket No. 2003N-0561"],"dockets":[],"document_number":"04-22210","effective_on":"2004-10-04","end_page":59134,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2004/10/04/04-22210.xml","html_url":"https://www.federalregister.gov/documents/2004/10/04/04-22210/orthopedic-devices-effective-date-of-requirement-for-premarket-approval-for-hip-joint-metalpolymer","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/04-22210?publication_date=2004-10-04","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2004-10-04/04-22210/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":62,"last_updated":"2026-09-21 08:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2004-10-04/pdf/04-22210.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2004-10-04","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2004/10/04/04-22210.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-11-12T13:57:12Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":59132,"subtype":null,"title":"Orthopedic Devices; Effective Date of Requirement for Premarket Approval for Hip Joint Metal/Polymer or Ceramic/Polymer Semiconstrained Resurfacing Cemented Prosthesis","toc_doc":"Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prothesis; premarket approval procedure","toc_subject":"Medical devices:","topics":["Medical devices"],"type":"Rule","volume":69}