{"abstract":"The Food and Drug Administration (FDA) proposes to amend the combination product regulations to set forth postmarketing safety reporting requirements for combination products. Specifically, the rule will clarify the postmarketing safety reporting requirements that apply when regulated articles (drugs, devices, and biological products) are combined to create a combination product. The proposed rule is intended to promote and protect the public health by clarifying requirements for postmarketing safety reporting for combination products, and is part of FDA's ongoing effort to ensure the consistency and appropriateness of the regulatory requirements for combination products.","action":"Proposed 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/2009/10/01/E9-23519.html","cfr_references":[{"chapter":null,"citation_url":null,"part":4,"title":21}],"citation":"74 FR 50744","comment_url":null,"comments_close_on":"2009-12-30","correction_of":null,"corrections":[],"dates":"Submit written or electronic comments on the proposed rule by December 30, 2009. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by November 2, 2009, (see the \"Paperwork Reduction Act of 1995\" section of this document).","disposition_notes":null,"docket_ids":["Docket No. FDA-2008-N-0424"],"dockets":[],"document_number":"E9-23519","effective_on":null,"end_page":50758,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2009/10/01/E9-23519.xml","html_url":"https://www.federalregister.gov/documents/2009/10/01/E9-23519/postmarketing-safety-reporting-for-combination-products","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/E9-23519?publication_date=2009-10-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2009-10-01/E9-23519/mods.xml","not_received_for_publication":null,"page_length":15,"page_views":{"count":3385,"last_updated":"2026-08-24 14:15:12 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2009-10-01/pdf/E9-23519.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2009-10-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2009/10/01/E9-23519.txt","regulation_id_number_info":{"0910-AF82":{"issue":"201610","html_url":"https://www.federalregister.gov/regulations/0910-AF82/postmarket-safety-reporting-for-combination-products","title":"Postmarket Safety Reporting for Combination Products","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201610&RIN=0910-AF82&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AF82"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Regulatory Impact Assessment for Postmarketing Safety Reporting for Combination Products ","document_id":"FDA-2008-N-0424-0021"},{"title":"DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION PUBLIC HEARING ON: FDA REGULATION OF  COMBINATION PRODUCTS","document_id":"FDA-2008-N-0424-0020"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2008-N-0424","supporting_documents_count":2,"docket_id":"FDA-2008-N-0424","regulation_id_number":null,"title":"Postmarketing Safety Reporting for Combination Products","checked_regulationsdotgov_at":"2010-07-19T13:51:31Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":50744,"subtype":null,"title":"Postmarketing Safety Reporting for Combination Products","toc_doc":"Postmarketing Safety Reporting for Combination Products","toc_subject":null,"topics":["Drugs"],"type":"Proposed Rule","volume":74}