{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled \"Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.\" This guidance identifies cybersecurity issues that manufacturers should consider in preparing premarket submissions for medical devices in order to maintain information confidentiality, integrity, and availability.","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/2014/10/02/2014-23457.html","cfr_references":[],"citation":"79 FR 59493","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-D-0616"],"dockets":[],"document_number":"2014-23457","effective_on":null,"end_page":59494,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/10/02/2014-23457.xml","html_url":"https://www.federalregister.gov/documents/2014/10/02/2014-23457/content-of-premarket-submissions-for-management-of-cybersecurity-in-medical-devices-guidance-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-23457?publication_date=2014-10-02","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-10-02/2014-23457/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":6796,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-10-02/pdf/2014-23457.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-23457.pdf?1412167755","publication_date":"2014-10-02","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/10/02/2014-23457.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-2013-D-0616","supporting_documents_count":0,"docket_id":"FDA-2013-D-0616","regulation_id_number":null,"title":"Content of Premarket Submissions for Management of Information Security in Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","checked_regulationsdotgov_at":"2015-01-12T19:43:20Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":59493,"subtype":null,"title":"Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Content of Premarket Submissions for Management of Cybersecurity in Medical Devices","toc_subject":"Guidance for Industry and Staff:","topics":[],"type":"Notice","volume":79}