{"abstract":"The Food and Drug Administration (FDA or Agency) is issuing regulations to set forth postmarketing safety reporting requirements for combination products. Specifically, this final rule describes the postmarketing safety reporting requirements that apply when two or more different types of regulated medical products (drugs, devices, and/or biological products, which are referred to as \"constituent parts\" of a combination product) comprise a combination product and the combination product or its constituent parts have received FDA marketing authorization. The rule is intended to promote and protect the public health by setting forth the requirements for postmarketing safety reporting for these combination products, and is part of FDA's ongoing effort to ensure the consistency and appropriateness of the regulatory requirements for combination products.","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/2016/12/20/2016-30485.html","cfr_references":[{"chapter":null,"citation_url":null,"part":4,"title":21}],"citation":"81 FR 92603","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Effective date: This rule is effective on January 19, 2017.","disposition_notes":null,"docket_ids":["Docket No. FDA-2008-N-0424"],"dockets":[],"document_number":"2016-30485","effective_on":"2017-01-19","end_page":92626,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/12/20/2016-30485.xml","html_url":"https://www.federalregister.gov/documents/2016/12/20/2016-30485/postmarketing-safety-reporting-for-combination-products","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-30485?publication_date=2016-12-20","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-12-20/2016-30485/mods.xml","not_received_for_publication":null,"page_length":24,"page_views":{"count":21968,"last_updated":"2026-08-25 12:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-12-20/pdf/2016-30485.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-30485.pdf?1482155157","publication_date":"2016-12-20","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/12/20/2016-30485.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":"2017-01-09T06:00:16Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":92603,"subtype":null,"title":"Postmarketing Safety Reporting for Combination Products","toc_doc":"Postmarketing Safety Reporting for Combination Products","toc_subject":null,"topics":["Drugs","Medical devices","Reporting and recordkeeping requirements","Safety"],"type":"Rule","volume":81}