{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance entitled \"Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under section 524B of the FD&C Act of the FD&C Act.\" FDA generally intends not to issue \"refuse to accept\" (RTA) decisions for premarket submissions submitted for cyber devices based solely on information required by the new amendments to the FD&C Act for ensuring cybersecurity of devices before October 1, 2023, but instead, work collaboratively with sponsors of such premarket submissions as part of the interactive and/or deficiency review process.","action":"Notice of availability.","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/2023/03/30/2023-06646.html","cfr_references":[],"citation":"88 FR 19148","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on March 30, 2023.","disposition_notes":null,"docket_ids":["Docket No. FDA-2023-D-1030"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2023-03-30","updated_at":"2023-04-10T16:56:16.719-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-D-0266-0001","allow_late_comments":null,"id":"FDA-2023-D-0266-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2023-D-0266","title":"Identification of Medicinal Products--Implementation and Use; Draft Guidance for Industry; Availability"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":null,"updated_at":"2023-03-30T14:56:42.312-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-D-1030-0001","allow_late_comments":null,"id":"FDA-2023-D-1030-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2023-D-1030","title":"Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act; Guidance for Industry and Food and Drug Administration Staff; Availability"}],"document_number":"2023-06646","effective_on":null,"end_page":19150,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/03/30/2023-06646.xml","html_url":"https://www.federalregister.gov/documents/2023/03/30/2023-06646/cybersecurity-in-medical-devices-refuse-to-accept-policy-for-cyber-devices-and-related-systems-under","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-06646?publication_date=2023-03-30","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-03-30/2023-06646/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":6913,"last_updated":"2026-05-29 12:15:10 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-03-30/pdf/2023-06646.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-06646.pdf?1680093938","publication_date":"2023-03-30","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/03/30/2023-06646.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-2023-D-0266","supporting_documents_count":0,"docket_id":"FDA-2023-D-0266","document_id":"FDA-2023-D-0266-0001","regulation_id_number":null,"title":"Identification of Medicinal Products--Implementation and Use; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2023-04-11T14:00:10Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":19148,"subtype":null,"title":"Cybersecurity in Medical Devices: Refuse To Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act; Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Cybersecurity in Medical Devices:  Refuse to Accept Policy for Cyber Devices and Related Systems under the Federal Food, Drug, and Cosmetic Act","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":88}