{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled \"Artificial Intelligence Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.\" This draft guidance, when finalized, will provide recommendations regarding the contents of marketing submissions for devices that include artificial intelligence (AI)-enabled device software functions including documentation and information that will support FDA's evaluation of safety and effectiveness. To support the development of appropriate documentation for FDA's assessment of the device, this draft guidance also proposes recommendations for the design, development, and implementation of AI- enabled devices that sponsors may wish to consider using throughout the total product lifecycle (TPLC). This draft guidance is not final nor is it for implementation at this time.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2025/01/07/2024-31543.html","cfr_references":[],"citation":"90 FR 1154","comment_url":null,"comments_close_on":"2025-04-07","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by April 7, 2025 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2024-D-4488"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":null,"updated_at":"2025-01-10T11:56:39.628-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-D-4488-0001","allow_late_comments":false,"id":"FDA-2024-D-4488-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2024-D-4488","title":"Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability"}],"document_number":"2024-31543","effective_on":null,"end_page":1156,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/01/07/2024-31543.xml","html_url":"https://www.federalregister.gov/documents/2025/01/07/2024-31543/artificial-intelligence-enabled-device-software-functions-lifecycle-management-and-marketing","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-31543?publication_date=2025-01-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-01-07/2024-31543/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":3968,"last_updated":"2026-08-18 16:15:15 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31543.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-31543.pdf?1736171123","publication_date":"2025-01-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/01/07/2024-31543.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-2024-D-4488","supporting_documents_count":0,"docket_id":"FDA-2024-D-4488","document_id":"FDA-2024-D-4488-0001","regulation_id_number":null,"title":"Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","checked_regulationsdotgov_at":"2025-01-11T15:00:11Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":1154,"subtype":null,"title":"Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations","toc_subject":"Guidance","topics":[],"type":"Notice","volume":90}