{"abstract":"The Food and Drug Administration (FDA or we) is announcing the availability of an update to the immediately in effect guidance for industry entitled \"Compliance Policy for Combination Product Postmarketing Safety Reporting.\" This guidance describes FDA's compliance policy for combination product applicants and constituent part applicants and activities under FDA regulations that addresses combination product postmarketing safety reporting. FDA is updating this guidance by extending the period of time during which FDA does not intend to enforce certain combination product postmarketing safety reporting requirements.","action":"Notification of availability.","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/2019/04/24/2019-08284.html","cfr_references":[{"chapter":null,"citation_url":null,"part":4,"title":21}],"citation":"84 FR 17081","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the updated guidance is published in the Federal Register on April 24, 2019.","disposition_notes":null,"docket_ids":["Docket No. FDA-2008-N-0424"],"dockets":[],"document_number":"2019-08284","effective_on":null,"end_page":17082,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2019/04/24/2019-08284.xml","html_url":"https://www.federalregister.gov/documents/2019/04/24/2019-08284/compliance-policy-for-combination-product-postmarketing-safety-reporting-immediately-in-effect","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2019-08284?publication_date=2019-04-24","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2019-04-24/2019-08284/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":953,"last_updated":"2026-08-26 04:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2019-04-24/pdf/2019-08284.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-08284.pdf?1556023538","publication_date":"2019-04-24","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2019/04/24/2019-08284.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"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":"2019-07-25T03:30:08Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":17081,"subtype":null,"title":"Compliance Policy for Combination Product Postmarketing Safety Reporting; Immediately in Effect Guidance for Industry; Availability","toc_doc":"Compliance Policy for Combination Product Postmarketing Safety Reporting","toc_subject":"Guidance:","topics":[],"type":"Rule","volume":84}