{"abstract":"The Food and Drug Administration (FDA or Agency) 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: 055\" (Recognition List Number: 055), 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/2021/04/29/2021-08992.html","cfr_references":[],"citation":"86 FR 22678","comment_url":null,"comments_close_on":"2021-04-29","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the notice at any time. These modifications to the list of recognized standards are applicable April 29, 2021.","disposition_notes":null,"docket_ids":["Docket No. FDA-2004-N-0451"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2021-04-29","updated_at":"2023-02-28T22:29:10.858-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2004-N-0451-0049","allow_late_comments":null,"id":"FDA-2004-N-0451-0049","comment_end_date":"2021-04-30","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":"2021-08992","effective_on":null,"end_page":22686,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/04/29/2021-08992.xml","html_url":"https://www.federalregister.gov/documents/2021/04/29/2021-08992/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/2021-08992?publication_date=2021-04-29","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-04-29/2021-08992/mods.xml","not_received_for_publication":null,"page_length":9,"page_views":{"count":2471,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-04-29/pdf/2021-08992.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-08992.pdf?1619613939","publication_date":"2021-04-29","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/04/29/2021-08992.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-0451-0049","regulation_id_number":null,"title":"Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards","checked_regulationsdotgov_at":"2023-03-01T03:29:09Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":22678,"subtype":null,"title":"Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 055","toc_doc":"Recognition List Number:  055","toc_subject":"Modifications to the List of Recognized Standards:\n","topics":[],"type":"Notice","volume":86}