{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled \"Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.\" This guidance identifies cybersecurity issues that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. This draft guidance is not final nor is it in effect at this time.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human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/2013/06/14/2013-14167.html","cfr_references":[],"citation":"78 FR 35940","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 12, 2013.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-D-0616"],"dockets":[],"document_number":"2013-14167","effective_on":null,"end_page":35940,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/06/14/2013-14167.xml","html_url":"https://www.federalregister.gov/documents/2013/06/14/2013-14167/content-of-premarket-submissions-for-management-of-cybersecurity-in-medical-devices-draft-guidance","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-14167?publication_date=2013-06-14","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-06-14/2013-14167/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":438,"last_updated":"2026-07-28 12:15:07 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-06-14/pdf/2013-14167.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-14167.pdf?1371127794","publication_date":"2013-06-14","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/06/14/2013-14167.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2013-08-04T05:00:39Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":35940,"subtype":null,"title":"Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft 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":"Draft Guidance for Industry and Staff; Availability:","topics":[],"type":"Notice","volume":78}