{"abstract":"The Food and Drug Administration (FDA) is amending its regulations to clarify that the Agency will provide an opportunity for an informal hearing in connection with a proposed rule to ban a device with a special effective date. This action is being taken to align the regulations with the Federal Food, Drug, and Cosmetic Act (the FD&C Act).","action":"Final rule; technical amendment.","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/2015/06/02/2015-13329.html","cfr_references":[{"chapter":null,"citation_url":null,"part":895,"title":21}],"citation":"80 FR 31299","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective June 2, 2015.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-N-0011"],"dockets":[],"document_number":"2015-13329","effective_on":"2015-06-02","end_page":31300,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/06/02/2015-13329.xml","html_url":"https://www.federalregister.gov/documents/2015/06/02/2015-13329/banned-devices-general-provisions-technical-amendment","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-13329?publication_date=2015-06-02","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-06-02/2015-13329/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":312,"last_updated":"2026-08-26 20:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-06-02/pdf/2015-13329.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-13329.pdf?1433162759","publication_date":"2015-06-02","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/06/02/2015-13329.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2015-N-0011","supporting_documents_count":0,"docket_id":"FDA-2015-N-0011","regulation_id_number":null,"title":"Technical Amendment","checked_regulationsdotgov_at":"2015-06-22T06:00:11Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":31299,"subtype":null,"title":"Banned Devices; General Provisions; Technical Amendment","toc_doc":"Banned Devices; General Provisions; Technical Amendments","toc_subject":null,"topics":["Administrative practice and procedure","Labeling","Medical devices"],"type":"Rule","volume":80}