{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its medical product \"intended use\" regulations. This action, if finalized, will amend FDA's regulations describing the types of evidence relevant to determining whether a product is intended for use as a drug or device under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Public Health Service Act (PHS Act), and FDA's implementing regulations, including whether an approved or cleared medical product is intended for a new use. This action will also repeal and replace the portions of a final rule issued on January 9, 2017, that never became effective. This action is intended to provide direction and clarity to regulated industry and other stakeholders.","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/2020/09/23/2020-20437.html","cfr_references":[{"chapter":null,"citation_url":null,"part":201,"title":21},{"chapter":null,"citation_url":null,"part":801,"title":21}],"citation":"85 FR 59718","comment_url":null,"comments_close_on":"2020-10-23","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the proposed rule by October 23, 2020.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-N-2002"],"dockets":[{"supporting_documents":[{"title":"REFERENCE 10 - Eguale, T., D.L. Buckeridge, A. Verma, et al RE Regulations Regarding Intended Uses","document_id":"FDA-2015-N-2002-2034"},{"title":"REFERENCE 3 -  Citizen Petition from the Medical Information Working Group at 18 RE Regulations Regarding Intended Uses","document_id":"FDA-2015-N-2002-2033"},{"title":"REFERENCE 2 -  Complaint at 35–37, Par Pharmaceutical Inc. v. United States RE Regulations Regarding Intended Uses","document_id":"FDA-2015-N-2002-2032"},{"title":"REFERENCE 1 - Plaintiff’s Memorandum of Law at 38–40, Allergan Inc. v. United States RE Regulations Regarding Intended Uses","document_id":"FDA-2015-N-2002-2031"},{"title":"Reference 7 DOJ_Atlanta Man Convicted of Illegally Importing and Distributing Male Enhancement Products from China re Regulations Regarding Intended Uses Amendments: Clarification of When Products Made or Derived From Tobacco are Regulated as Drugs, Devices, or Combination Products","document_id":"FDA-2015-N-2002-1987"},{"title":"Reference 4 United States v. Bowen, 14-cr-00169-PAB, Indictment (D. Colo. May 5, 2014) re Regulations Regarding Intended Uses Amendments: Clarification of When Products Made or Derived From Tobacco are Regulated as Drugs, Devices, or Combination Products","document_id":"FDA-2015-N-2002-1984"},{"title":"Reference 3 United States v. Carlson, 12-cr-00305-DSD-LIB, Court’s Instructions to the Jury, (D. Minn. Oct. 8, 2013) re Regulations Regarding Intended Uses Amendments: Clarification of When Products Made or Derived From Tobacco are Regulated as Drugs, Devices, or Combination Products","document_id":"FDA-2015-N-2002-1983"},{"title":"Reference 1 United States v. LA Rush, 213-cr-00249, First Superseding Information (C.D. Cal. April 3, 2014) re Regulations Regarding Intended Uses Amendments: Clarification of When Products Made or Derived From Tobacco are Regulated as Drugs, Devices, or Combination Products","document_id":"FDA-2015-N-2002-1981"},{"title":"TAB C 2016-308 Jurisdiction RIA as Cleared by OMB.docx","document_id":"FDA-2015-N-2002-1975"},{"title":"TAB C 2016-308 Jurisdiction Final Rule as Cleared by OMB","document_id":"FDA-2015-N-2002-1974"}],"agency_name":"FDA","documents":[{"comment_count":16,"comment_start_date":"2020-09-23","updated_at":"2023-02-28T22:46:27.835-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2015-N-2002-2030","allow_late_comments":null,"id":"FDA-2015-N-2002-2030","comment_end_date":"2020-10-24","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":50,"id":"FDA-2015-N-2002","title":"Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products"}],"document_number":"2020-20437","effective_on":null,"end_page":59729,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/09/23/2020-20437.xml","html_url":"https://www.federalregister.gov/documents/2020/09/23/2020-20437/regulations-regarding-intended-uses","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-20437?publication_date=2020-09-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-09-23/2020-20437/mods.xml","not_received_for_publication":null,"page_length":12,"page_views":{"count":16189,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-09-23/pdf/2020-20437.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-20437.pdf?1600778716","publication_date":"2020-09-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/09/23/2020-20437.txt","regulation_id_number_info":{"0910-AI47":{"issue":"202104","html_url":"https://www.federalregister.gov/regulations/0910-AI47/regulations-regarding-intended-uses-","title":"Regulations Regarding \"Intended Uses\"","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202104&RIN=0910-AI47&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AI47"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"REFERENCE 10 - Eguale, T., D.L. 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