{"abstract":"As required by the 21st Century Cures Act (Cures Act), the Food and Drug Administration (FDA or Agency) is proposing a list of alternative or streamlined mechanisms for complying with the current good manufacturing practice (CGMP) requirements for combination products. Combination products are products composed of two or more different types of medical products (drug, device, and/or biological product).","action":"Notice.","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/2018/06/13/2018-12634.html","cfr_references":[],"citation":"83 FR 27609","comment_url":null,"comments_close_on":"2018-09-11","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on this notice by September 11, 2018 to ensure that the Agency considers your comment on this proposed list before it begins work on the final list.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-N-2065"],"dockets":[{"supporting_documents":[{"title":"Alternative or Streamlined Mechanisms for Complying with the Current Good Manufacturing Practice Requirements for Combination Products: List under the 21st Century Cures Act","document_id":"FDA-2018-N-2065-0008"},{"title":"Alternative or Streamlined Mechanisms for Complying With the Current Good Manufacturing Practice Requirements for Combination Products; Proposed List Under the 21st Century Cures Act","document_id":"FDA-2018-N-2065-0001"}],"agency_name":null,"documents":[{"comment_count":6,"comment_start_date":"2018-06-13","updated_at":"2023-03-01T01:39:41.950-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2018-N-2065-0001","allow_late_comments":null,"id":"FDA-2018-N-2065-0001","comment_end_date":"2018-09-12","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":2,"id":"FDA-2018-N-2065","title":"Alternative or Streamlined Mechanisms for Complying with the Current Good Manufacturing Practice (CGMP) Requirements for Combination Products; Proposed List Pursuant to Section 3038(c) of the 21st Century Cures Act"}],"document_number":"2018-12634","effective_on":null,"end_page":27614,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/06/13/2018-12634.xml","html_url":"https://www.federalregister.gov/documents/2018/06/13/2018-12634/alternative-or-streamlined-mechanisms-for-complying-with-the-current-good-manufacturing-practice","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-12634?publication_date=2018-06-13","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-06-13/2018-12634/mods.xml","not_received_for_publication":null,"page_length":6,"page_views":{"count":3622,"last_updated":"2026-09-22 22:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-06-13/pdf/2018-12634.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-12634.pdf?1528807516","publication_date":"2018-06-13","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/06/13/2018-12634.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Alternative or Streamlined Mechanisms for Complying with the Current Good Manufacturing Practice Requirements for Combination Products: List under the 21st Century Cures Act","document_id":"FDA-2018-N-2065-0008"},{"title":"Alternative or Streamlined Mechanisms for Complying With the Current Good Manufacturing Practice Requirements for Combination Products; Proposed List Under the 21st Century Cures Act","document_id":"FDA-2018-N-2065-0001"}],"comments_count":6,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2018-N-2065","supporting_documents_count":2,"docket_id":"FDA-2018-N-2065","document_id":"FDA-2018-N-2065-0001","regulation_id_number":null,"title":"Alternative or Streamlined Mechanisms for Complying with the Current Good Manufacturing Practice (CGMP) Requirements for Combination Products; Proposed List Pursuant to Section 3038(c) of the 21st Century Cures Act","checked_regulationsdotgov_at":"2023-03-01T06:39:41Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":27609,"subtype":null,"title":"Alternative or Streamlined Mechanisms for Complying With the Current Good Manufacturing Practice Requirements for Combination Products; Proposed List Under the 21st Century Cures Act","toc_doc":"Proposed List of Alternative or Streamlined Mechanisms for Complying with Current Good Manufacturing Practice Requirements for Combination Products","toc_subject":null,"topics":[],"type":"Notice","volume":83}