{"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). This publication, entitled \"Modifications to the List of Recognized Standards, Recognition List Number: 038\" (Recognition List Number: 038), 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/2015/01/27/2015-01420.html","cfr_references":[],"citation":"80 FR 4274","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 VII of this document 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":"2015-01-27","updated_at":"2023-08-07T14:56:22.506-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2004-N-0451-0031","allow_late_comments":null,"id":"FDA-2004-N-0451-0031","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":"2015-01420","effective_on":null,"end_page":4280,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/01/27/2015-01420.xml","html_url":"https://www.federalregister.gov/documents/2015/01/27/2015-01420/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/2015-01420?publication_date=2015-01-27","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-01-27/2015-01420/mods.xml","not_received_for_publication":null,"page_length":7,"page_views":{"count":871,"last_updated":"2026-07-27 14:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-01-27/pdf/2015-01420.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-01420.pdf?1422280722","publication_date":"2015-01-27","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/01/27/2015-01420.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-0451-0031","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":4274,"subtype":null,"title":"Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 038","toc_doc":"List of Recognized Standards, Recognition List Number 038; Modifications","toc_subject":"Food and Drug Administration Modernization Act:","topics":[],"type":"Notice","volume":80}