{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance entitled \"Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions.\" This guidance demonstrates FDA's commitment to developing innovative approaches to the regulation of artificial intelligence (AI)-enabled devices. More specifically, this guidance provides recommendations on the information to include in a Predetermined Change Control Plan (PCCP) in a marketing submission for a device that includes one or more AI-enabled device software functions (AI-DSFs). This guidance recommends that a PCCP describe the planned AI-DSF modifications, the associated methodology to develop, validate, and implement those modifications, and an assessment of the impact of those modifications. FDA reviews the PCCP as part of a marketing submission for a device to ensure the continued safety and effectiveness of the device without necessitating additional marketing submissions for implementing each modification described in the PCCP.","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/2024/12/04/2024-28361.html","cfr_references":[],"citation":"89 FR 96259","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on December 4, 2024.","disposition_notes":null,"docket_ids":["Docket No. FDA-2022-D-2628"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":null,"comment_start_date":null,"updated_at":"2024-12-04T09:56:37.510-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-D-2628-0035","allow_late_comments":false,"id":"FDA-2022-D-2628-0035","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2022-D-2628","title":"Marketing Submission Recommendations for a Modification Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability"}],"document_number":"2024-28361","effective_on":null,"end_page":96261,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/12/04/2024-28361.xml","html_url":"https://www.federalregister.gov/documents/2024/12/04/2024-28361/marketing-submission-recommendations-for-a-predetermined-change-control-plan-for-artificial","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-28361?publication_date=2024-12-04","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-12-04/2024-28361/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1892,"last_updated":"2026-06-10 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-12-04/pdf/2024-28361.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-28361.pdf?1733233522","publication_date":"2024-12-04","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/12/04/2024-28361.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-2022-D-2628","supporting_documents_count":0,"docket_id":"FDA-2022-D-2628","document_id":"FDA-2022-D-2628-0035","regulation_id_number":null,"title":"Marketing Submission Recommendations for a Modification Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","checked_regulationsdotgov_at":"2024-12-05T14:00:13Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":96259,"subtype":null,"title":"Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions; Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions","toc_subject":"Guidance","topics":[],"type":"Notice","volume":89}