id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id FDA-2022-D-2628-0037,FDA,FDA-2022-D-2628,Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions,Other,Guidance,2025-08-18T04:00:00Z,2025,8,2025-08-18T04:00:00Z,,2025-08-18T23:01:50Z,,1,0,09000064b8f05d13 FDA-2022-D-2628-0036,FDA,FDA-2022-D-2628,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,Other,Guidance,2024-12-04T05:00:00Z,2024,12,2024-12-04T05:00:00Z,,2024-12-04T14:40:28Z,,1,0,0900006486848e1f FDA-2022-D-2628-0035,FDA,FDA-2022-D-2628,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,Notice,Notice of Availability,2024-12-04T05:00:00Z,2024,12,,,2024-12-04T14:43:53Z,2024-28361,0,0,0900006486848770 FDA-2022-D-2628-0002,FDA,FDA-2022-D-2628,Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions Draft Guidance for Industry and Food and Drug Administration Staff; DRAFT GUIDANCE,Other,Guidance,2023-04-03T04:00:00Z,2023,4,2023-04-03T04:00:00Z,2023-07-04T03:59:59Z,2024-11-12T23:53:25Z,,1,0,09000064858c5832 FDA-2022-D-2628-0001,FDA,FDA-2022-D-2628,"Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning-Enabled Device Software Functions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability",Notice,Notice of Availability,2023-04-03T04:00:00Z,2023,4,2023-04-03T04:00:00Z,,2023-04-03T13:22:21Z,2023-06786,0,0,09000064858c4bc4