{"abstract":"The Food and Drug Administration (FDA) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (\"FDA Recognized Consensus Standards\"). Specifically, this publication announces the addition of a list of recognized standards that are relevant to safety considerations to mitigate the risks of misconnections with small-bore connectors intended for enteral applications. This publication, entitled \"Modifications to the List of Recognized Standards, Recognition List Number: 039\" (\"Recognition List Number: 039\"), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.","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/2015/02/11/2015-02801.html","cfr_references":[],"citation":"80 FR 7617","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments concerning this document at any time. See section VI for the effective date of the recognition of standards announced in this document.","disposition_notes":null,"docket_ids":["Docket No. FDA-2004-N-0451"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2015-02-11","updated_at":"2023-08-07T14:56:30.068-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2004-N-0451-0032","allow_late_comments":null,"id":"FDA-2004-N-0451-0032","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2004-N-0451","title":"Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards"}],"document_number":"2015-02801","effective_on":null,"end_page":7619,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/02/11/2015-02801.xml","html_url":"https://www.federalregister.gov/documents/2015/02/11/2015-02801/food-and-drug-administration-modernization-act-of-1997-modifications-to-the-list-of-recognized","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-02801?publication_date=2015-02-11","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-02-11/2015-02801/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":293,"last_updated":"2026-08-24 06:15:07 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-02-11/pdf/2015-02801.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-02801.pdf?1423576478","publication_date":"2015-02-11","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/02/11/2015-02801.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2004-N-0451","supporting_documents_count":0,"docket_id":"FDA-2004-N-0451","document_id":"FDA-2004-N-0451-0032","regulation_id_number":null,"title":"Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards","checked_regulationsdotgov_at":"2023-08-08T18:00:12Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":7617,"subtype":null,"title":"Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 039","toc_doc":"Modifications to the List of Recognized Standards","toc_subject":null,"topics":[],"type":"Notice","volume":80}