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withdrawn,object_id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-2024-N-4016-0010,FDA,FDA-2024-N-4016,"Revocation of Regulations Regarding the Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and the European Community",Rule,Final Rule,2026-02-19T05:00:00Z,2026,2,2026-02-19T05:00:00Z,,2026-02-19T20:44:43Z,2026-03286,0,0,09000064b91bd3cf
FDA-2020-N-1383-0042,FDA,FDA-2020-N-1383,Revocation of Methods of Analysis Regulation,Rule,Final Rule,2026-02-19T05:00:00Z,2026,2,2026-02-19T05:00:00Z,,2026-02-19T20:49:20Z,2026-03285,0,0,09000064b91bd38a
FDA-2024-C-3384-0003,FDA,FDA-2024-C-3384,Listing of Color Additives Exempt From Certification; Spirulina Extract,Rule,Final Rule,2026-02-06T05:00:00Z,2026,2,2026-02-06T05:00:00Z,2026-03-10T03:59:59Z,2026-02-20T20:30:11Z,2026-02314,1,0,09000064b9195bcf
FDA-2025-N-0002-0004,FDA,FDA-2025-N-0002,"New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug
Application; Change of Sponsor; Change of Sponsor Address",Rule,Final Rule,2026-02-06T05:00:00Z,2026,2,2026-02-06T05:00:00Z,,2026-02-06T20:40:05Z,2026-02331,0,0,09000064b9195a5c
FDA-2024-C-1085-0003,FDA,FDA-2024-C-1085,Listing of Color Additives Exempt From Certification; Beetroot Red,Rule,Final Rule,2026-02-06T05:00:00Z,2026,2,2026-02-06T05:00:00Z,2026-03-10T03:59:59Z,2026-03-01T10:00:12Z,2026-02313,1,0,09000064b91929e7
FDA-2025-N-6025-0001,FDA,FDA-2025-N-6025,Medical Devices; Neurological Devices; Classification of the Electrical Tongue Nerve Stimulator To Treat Motor Deficits,Rule,Final Rule,2025-12-19T05:00:00Z,2025,12,2025-12-19T05:00:00Z,,2025-12-19T21:24:58Z,2025-23413,0,0,09000064b90eed4c
FDA-2025-N-4635-0001,FDA,FDA-2025-N-4635,Medical Devices; Quality Management System Regulation Technical Amendments,Rule,Final Rule,2025-12-04T05:00:00Z,2025,12,2025-12-04T05:00:00Z,,2025-12-04T20:51:36Z,2025-21955,0,0,09000064b90addd8
FDA-2025-N-4680-0001,FDA,FDA-2025-N-4680,Medical Devices; Neurological Devices; Classification of Field Generator Positioning Device,Rule,Final Rule,2025-11-26T05:00:00Z,2025,11,,,2025-11-26T19:18:25Z,2025-21218,0,0,09000064b909eb80
FDA-2025-N-4645-0001,FDA,FDA-2025-N-4645,Medical Devices; Gastroenterology-Urology Devices; Classification of the Anchored Esophageal Sheath,Rule,Final Rule,2025-11-26T05:00:00Z,2025,11,,,2025-11-26T19:27:15Z,2025-21217,0,0,09000064b9099738
FDA-2021-C-0522-0008,FDA,FDA-2021-C-0522,Listing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue; Confirmation of Effective Date,Rule,Confirmation of Effective Date,2025-10-01T04:00:00Z,2025,10,2025-10-01T04:00:00Z,,2025-10-01T16:19:10Z,2025-19166,0,0,09000064b8feca5c
FDA-2025-N-1184-0013,FDA,FDA-2025-N-1184,Revocation of Food Standards for 11 Products Not Currently Sold; Confirmation of Effective Date,Rule,Direct Final Rule,2025-09-26T04:00:00Z,2025,9,2025-09-26T04:00:00Z,,2025-09-26T20:06:47Z,2025-18730,0,0,09000064b8fdf0a2
FDA-2011-N-0179-0040,FDA,FDA-2011-N-0179,Prior Notice: Adding Requirement To Submit Mail Tracking Number for Articles of Food Arriving by International Mail and Timeframe for Post-Refusal and Post-Hold Submissions,Rule,Final Rule,2025-09-25T04:00:00Z,2025,9,,,2025-09-25T18:43:29Z,2025-18655,0,0,09000064b8fdc155
FDA-2025-N-0002-0003,FDA,FDA-2025-N-0002,New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address; Correction,Rule,Correction,2025-09-19T04:00:00Z,2025,9,2025-09-19T04:00:00Z,,2025-09-19T18:10:54Z,2025-18217,0,0,09000064b8fba369
FDA-2025-N-1730-0001,FDA,FDA-2025-N-1730,Regulation Identification Number 0910–AJ05 Medical Devices; Laboratory Developed Tests; Implementation of Vacatur,Rule,Final Rule,2025-09-19T04:00:00Z,2025,9,2025-09-19T04:00:00Z,,2025-09-19T18:14:38Z,2025-18239,0,0,09000064b8fb1036
FDA-2018-N-3303-0024,FDA,FDA-2018-N-3303,Radiological Health Regulations; Technical Amendments,Rule,Final Rule,2025-09-18T04:00:00Z,2025,9,2025-09-18T04:00:00Z,,2025-09-18T18:59:50Z,2025-18080,0,0,09000064b8fb0f97
FDA-2024-N-3533-0032,FDA,FDA-2024-N-3533,"Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices",Rule,Final Rule,2025-09-18T04:00:00Z,2025,9,2025-09-18T04:00:00Z,,2025-09-18T18:53:51Z,2025-18082,0,0,09000064b8fb1032
FDA-2021-F-0366-0002,FDA,FDA-2021-F-0366,"Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3 in Yogurt and Other Cultured Dairy Products Fermented With Lactobacillus delbrueckii, Subspecies bulgaricus, and Streptococcus thermophilus",Rule,Final Rule,2025-09-04T04:00:00Z,2025,9,2025-09-04T04:00:00Z,2025-10-07T03:59:59Z,2025-10-07T01:16:03Z,2025-16946,0,0,09000064b8f40d02
FDA-2022-F-2725-0008,FDA,FDA-2022-F-2725,Secondary Direct Food Additives Permitted in Food for Human Consumption; Hydrogen Peroxide,Rule,Final Rule,2025-09-03T04:00:00Z,2025,9,2025-09-03T04:00:00Z,2025-10-04T03:59:59Z,2025-10-07T01:16:03Z,2025-16898,0,0,09000064b8f38e11
FDA-2025-N-2427-0001,FDA,FDA-2025-N-2427,Advisory Committee; Arthritis Advisory Committee; Termination; Removal From List of Standing Committees,Rule,Final Rule,2025-08-29T04:00:00Z,2025,8,,,2025-08-29T17:17:40Z,2025-16629,0,0,09000064b8f25fe7
FDA-2025-N-0002-0002,FDA,FDA-2025-N-0002,"New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug
Applications; Change of Sponsor; Change of Sponsor Address",Rule,Final Rule,2025-08-22T04:00:00Z,2025,8,2025-08-22T04:00:00Z,,2025-08-22T17:34:47Z,2025-16079,0,0,09000064b8f0b41a
FDA-2025-N-2107-0001,FDA,FDA-2025-N-2107,Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Menopause Test System,Rule,Final Rule,2025-08-21T04:00:00Z,2025,8,,,2025-08-21T17:51:06Z,2025-16036,0,0,09000064b8f0b22d
FDA-2025-N-2106-0001,FDA,FDA-2025-N-2106,Medical Devices; Immunology and Microbiology Devices; Classification of the Device That Detects Nucleic Acid Sequences From Microorganisms Associated With Vaginitis and Bacterial Vaginosis,Rule,Final Rule,2025-08-21T04:00:00Z,2025,8,,,2025-08-21T17:03:43Z,2025-16030,0,0,09000064b8f0b385
FDA-2025-N-2520-0001,FDA,FDA-2025-N-2520,Medical Devices; Orthopedic Devices; Classification of Orthopedic Manual Surgical Instrumentation for Use With Total Disc Replacement Devices,Rule,Final Rule,2025-08-21T04:00:00Z,2025,8,,,2025-08-21T17:08:45Z,2025-16039,0,0,09000064b8f0b382
FDA-2025-N-2788-0001,FDA,FDA-2025-N-2788,Medical Devices; Immunology and Microbiology Devices; Classification of A Multiplex Respiratory Panel To Detect and Identify Emerging Respiratory Pathogen(s) and Common Respiratory Pathogens in Human Clinical Specimens,Rule,Final Rule,2025-08-21T04:00:00Z,2025,8,,,2025-08-21T17:33:55Z,2025-16034,0,0,09000064b8f0b2f1
FDA-2024-C-0971-0009,FDA,FDA-2024-C-0971,Listing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract; Confirmation of Effective Date,Rule,Confirmation of Effective Date,2025-08-21T04:00:00Z,2025,8,,,2025-08-21T17:22:33Z,2025-16045,0,0,09000064b8f0b33c
FDA-2025-N-2523-0001,FDA,FDA-2025-N-2523,Medical Devices; Orthopedic Devices; Classification of Orthopedic Manual Surgical Instrumentation for Use With Non-Fusion Spinous Process Spacer Devices,Rule,Final Rule,2025-08-21T04:00:00Z,2025,8,,,2025-08-21T17:41:21Z,2025-16040,0,0,09000064b8f0b2b9
FDA-2023-C-0544-0010,FDA,FDA-2023-C-0544,Listing of Color Additives Exempt From Certification; Calcium Phosphate; Confirmation of Effective Date,Rule,Confirmation of Effective Date,2025-08-21T04:00:00Z,2025,8,,,2025-08-21T17:30:28Z,2025-16047,0,0,09000064b8f0b2f5
FDA-2021-C-0925-0007,FDA,FDA-2021-C-0925,Listing of Color Additives Exempt From Certification; Galdieria Extract Blue; Confirmation of Effective Date,Rule,Confirmation of Effective Date,2025-08-21T04:00:00Z,2025,8,,,2025-08-21T16:53:21Z,2025-16046,0,0,09000064b8f0b3ce
FDA-2025-N-2369-0001,FDA,FDA-2025-N-2369,Medical Devices; Radiology Devices; Classification of the Liver Iron Concentration Imaging Companion Diagnostic for Deferasirox,Rule,Final Rule,2025-08-21T04:00:00Z,2025,8,,,2025-08-21T16:47:29Z,2025-16033,0,0,09000064b8f0b3d1
FDA-2025-N-2219-0001,FDA,FDA-2025-N-2219,Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Pharmacogenetic Assessment System,Rule,Final Rule,2025-08-21T04:00:00Z,2025,8,,,2025-08-21T17:13:17Z,2025-16037,0,0,09000064b8f0b340
FDA-2025-N-2108-0001,FDA,FDA-2025-N-2108,Medical Devices; Immunology and Microbiology Devices; Classification of the Anti-Phospholipase A2 Receptor Immunological Test System,Rule,Final Rule,2025-08-21T04:00:00Z,2025,8,,,2025-08-21T16:57:13Z,2025-16031,0,0,09000064b8f0b386
FDA-2025-N-2424-0001,FDA,FDA-2025-N-2424,Medical Devices; Immunology and Microbiology Devices; Classification of the Mutation Detection Test for Myeloproliferative Neoplasms,Rule,Final Rule,2025-08-21T04:00:00Z,2025,8,,,2025-08-21T17:44:12Z,2025-16038,0,0,09000064b8f0b275
FDA-2025-N-2110-0001,FDA,FDA-2025-N-2110,Medical Devices; Immunology and Microbiology Devices; Classification of the Postnatal Chromosomal Copy Number Variation Detection System,Rule,Final Rule,2025-08-21T04:00:00Z,2025,8,,,2025-08-21T17:39:13Z,2025-16032,0,0,09000064b8f0b2ba
FDA-2025-N-2425-0001,FDA,FDA-2025-N-2425,Medical Devices; Immunology and Microbiology Devices; Classification of the Cancer Predisposition Risk Assessment System,Rule,Final Rule,2025-08-21T04:00:00Z,2025,8,,,2025-08-21T17:26:12Z,2025-16035,0,0,09000064b8f0b337
FDA-2025-N-2823-0001,FDA,FDA-2025-N-2823,Medical Devices; Gastroenterology-Urology Devices; Classification of the Laparoscopic Gastrointestinal Sizing Tool,Rule,Final Rule,2025-08-21T04:00:00Z,2025,8,,,2025-08-21T17:17:47Z,2025-16041,0,0,09000064b8f0b33d
FDA-2021-C-0522-0007,FDA,FDA-2021-C-0522,Listing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue; Correction,Rule,Correction,2025-08-06T04:00:00Z,2025,8,2025-08-06T04:00:00Z,,2025-08-06T16:56:26Z,2025-14905,0,0,09000064b8ee52f1
FDA-2025-N-0009-0001,FDA,FDA-2025-N-0009,Regulatory Hearing Before the Food and Drug Administration; CFR Correction,Rule,Final Rule,2025-07-28T04:00:00Z,2025,7,,,2025-07-28T18:15:51Z,2025-14203,0,0,09000064b8ead960
FDA-2025-N-1184-0002,FDA,FDA-2025-N-1184,Revocation of Food Standards for 11 Products Not Currently Sold,Rule,Direct Final Rule,2025-07-17T04:00:00Z,2025,7,2025-07-17T04:00:00Z,2025-08-19T03:59:59Z,2025-08-15T09:00:09Z,2025-13421,0,0,09000064b8e7ef18
FDA-2021-C-0522-0002,FDA,FDA-2021-C-0522,Listing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue,Rule,Final Rule,2025-07-15T04:00:00Z,2025,7,2025-07-15T04:00:00Z,2025-08-15T03:59:59Z,2025-07-15T16:29:34Z,2025-13175,0,0,09000064b8e76573
FDA-2025-N-1264-0001,FDA,FDA-2025-N-1264,Medical Devices; Hematology and Pathology Devices; Classification of the Fluorescence In Situ Hybridization-Based Detection of Chromosomal Abnormalities From Patients With Hematologic Malignancies,Rule,Final Rule,2025-06-26T04:00:00Z,2025,6,2025-06-26T04:00:00Z,,2025-06-26T17:27:00Z,2025-11793,0,0,09000064b8e322d7
FDA-2025-N-1245-0001,FDA,FDA-2025-N-1245,"Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Muscular
Dystrophy Newborn Screening Test",Rule,Final Rule,2025-06-26T04:00:00Z,2025,6,2025-06-26T04:00:00Z,,2025-06-26T17:59:58Z,2025-11796,0,0,09000064b8e321d0
FDA-2025-N-1448-0001,FDA,FDA-2025-N-1448,Medical Devices; Immunology and Microbiology Devices; Classification of the Herpes Simplex Virus Nucleic Acid-Based Assay for Central Nervous System Infections,Rule,Final Rule,2025-06-26T04:00:00Z,2025,6,2025-06-26T04:00:00Z,,2025-06-26T17:51:03Z,2025-11794,0,0,09000064b8e32217
FDA-2025-N-1447-0001,FDA,FDA-2025-N-1447,"Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Lysosomal
Storage Disorder Newborn Screening Test System",Rule,Final Rule,2025-06-26T04:00:00Z,2025,6,2025-06-26T04:00:00Z,,2025-06-26T17:53:22Z,2025-11781,0,0,09000064b8e32214
FDA-2025-N-1361-0001,FDA,FDA-2025-N-1361,Medical Devices; Radiology Devices; Classification of the Cream for X-Ray Attenuation,Rule,Final Rule,2025-06-26T04:00:00Z,2025,6,2025-06-26T04:00:00Z,,2025-06-26T17:06:47Z,2025-11791,0,0,09000064b8e32366
FDA-2023-N-4372-0005,FDA,FDA-2023-N-4372,Medical Devices: Exemptions from Premarket Notification: Class II Devices; Clinical Electronic Thermometers,Rule,Final Rule,2025-06-18T04:00:00Z,2025,6,,,2025-06-18T16:02:14Z,2025-11207,0,0,09000064b8e17430
FDA-2025-N-1262-0001,FDA,FDA-2025-N-1262,"Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify
Fungal Nucleic Acids Directly in Respiratory Specimens",Rule,Final Rule,2025-06-13T04:00:00Z,2025,6,2025-06-13T04:00:00Z,,2025-06-13T17:31:42Z,2025-10786,0,0,09000064b8e041ed
FDA-2025-N-1505-0001,FDA,FDA-2025-N-1505,"Medical Devices; Immunology and Microbiology Devices; Classification of the Clinical Mass Spectrometry
Microorganism Identification and Differentiation System",Rule,Final Rule,2025-06-13T04:00:00Z,2025,6,2025-06-13T04:00:00Z,,2025-06-13T17:34:14Z,2025-10788,0,0,09000064b8e041ea
FDA-2025-N-1529-0001,FDA,FDA-2025-N-1529,"Medical Devices; Radiology Devices; Classification of the Radiological Computer-Assisted Detection and
Diagnosis Software",Rule,Final Rule,2025-06-13T04:00:00Z,2025,6,2025-06-13T04:00:00Z,,2025-06-13T17:17:44Z,2025-10789,0,0,09000064b8e042ff
FDA-2025-N-1503-0001,FDA,FDA-2025-N-1503,"Medical Devices; Immunology and Microbiology Devices; Classification of the Cellular Analysis System for
Multiplexed Antimicrobial Susceptibility Testing",Rule,Final Rule,2025-06-13T04:00:00Z,2025,6,2025-06-13T04:00:00Z,,2025-06-13T17:14:18Z,2025-10787,0,0,09000064b8e04340
FDA-2025-N-1263-0001,FDA,FDA-2025-N-1263,Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect Bacterial Protease Activity in Chronic Wound Fluid,Rule,Final Rule,2025-06-02T04:00:00Z,2025,6,,,2025-06-03T00:21:49Z,2025-09883,0,0,09000064b8dcebee
FDA-2025-N-1182-0001,FDA,FDA-2025-N-1182,Medical Devices; Radiology Devices; Classification of the Radiological Acquisition and/or Optimization Guidance System,Rule,Final Rule,2025-06-02T04:00:00Z,2025,6,,,2025-06-03T00:23:13Z,2025-09837,0,0,09000064b8dceba3
FDA-2025-N-1281-0001,FDA,FDA-2025-N-1281,"Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Anti-Mullerian
Hormone Test System",Rule,Final Rule,2025-05-30T04:00:00Z,2025,5,2025-05-30T04:00:00Z,,2025-05-30T18:16:11Z,2025-09776,0,0,09000064b8dcb26a
FDA-2025-N-1159-0001,FDA,FDA-2025-N-1159,"Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Plazomicin Test
System",Rule,Final Rule,2025-05-29T00:00:00Z,2025,5,2025-05-29T00:00:00Z,,2025-05-29T18:34:10Z,2025-09638,0,0,09000064b8dc76a2
FDA-2025-N-1160-0001,FDA,FDA-2025-N-1160,Medical Devices; Immunology and Microbiology Devices; Classification of the Zika Virus Serological Reagents,Rule,Final Rule,2025-05-29T00:00:00Z,2025,5,2025-05-29T00:00:00Z,,2025-05-29T17:57:09Z,2025-09639,0,0,09000064b8dc77ac
FDA-2022-C-0098-0007,FDA,FDA-2022-C-0098,Listing of Color Additives; Myoglobin; Confirmation of Effective Date,Rule,Confirmation of Effective Date,2025-05-29T00:00:00Z,2025,5,2025-05-29T00:00:00Z,,2025-05-29T17:42:34Z,2025-09680,0,0,09000064b8dc77b5
FDA-2025-N-1163-0001,FDA,FDA-2025-N-1163,Medical Devices; Gastroenterology-Urology Devices; Classification of the Temporarily-Placed Urethral Opening System for Symptoms of Benign Prostatic Hyperplasia,Rule,Final Rule,2025-05-29T00:00:00Z,2025,5,2025-05-29T00:00:00Z,,2025-05-29T18:23:02Z,2025-09640,0,0,09000064b8dc7730
FDA-2025-N-1183-0001,FDA,FDA-2025-N-1183,"Medical Devices; Immunology and Microbiology Devices; Classification of the Inherited Nucleotide Repeat
Disorder Deoxyribonucleic Acid Test",Rule,Final Rule,2025-05-29T00:00:00Z,2025,5,2025-05-29T00:00:00Z,,2025-05-29T18:45:16Z,2025-09641,0,0,09000064b8dc27b8
FDA-2014-F-1184-0004,FDA,FDA-2014-F-1184,Food Additives Permitted in Feed and Drinking Water of Animals; Selenium,Rule,Final Rule,2025-05-19T04:00:00Z,2025,5,2025-05-19T04:00:00Z,2025-06-19T03:59:59Z,2025-06-19T09:00:14Z,2025-08864,0,0,09000064b8d7f9d3
FDA-2024-C-0971-0001,FDA,FDA-2024-C-0971,Listing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract,Rule,Final Rule,2025-05-12T04:00:00Z,2025,5,2025-05-12T04:00:00Z,2025-06-12T03:59:59Z,2025-06-03T09:00:19Z,2025-08248,0,0,09000064b8d3d224
FDA-2021-C-0925-0002,FDA,FDA-2021-C-0925,Listing of Color Additives Exempt From Certification; Galdieria Extract Blue,Rule,Final Rule,2025-05-12T04:00:00Z,2025,5,2025-05-12T04:00:00Z,2025-06-12T03:59:59Z,2025-05-21T22:32:39Z,2025-08250,0,0,09000064b8d3d2ae
FDA-2023-C-0544-0002,FDA,FDA-2023-C-0544,Listing of Color Additives Exempt From Certification; Calcium Phosphate,Rule,Final Rule,2025-05-12T04:00:00Z,2025,5,2025-05-12T04:00:00Z,2025-06-12T03:59:59Z,2025-06-12T09:00:19Z,2025-08249,0,0,09000064b8d3d374
FDA-2025-N-0781-0001,FDA,FDA-2025-N-0781,"Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Measure
Non-Microbial Analytes To Aid in the Detection and Identification of Localized Human Infections",Rule,Final Rule,2025-05-09T00:00:00Z,2025,5,2025-05-09T00:00:00Z,,2025-05-21T19:36:23Z,2025-08144,0,0,09000064b8d1fdb0
FDA-2025-N-0725-0001,FDA,FDA-2025-N-0725,"Medical Devices; Immunology and Microbiology Devices; Classification of the Cytomegalovirus Nucleic Acid
Detection Device for Congenital Cytomegalovirus Infection",Rule,Final Rule,2025-05-09T00:00:00Z,2025,5,2025-05-09T00:00:00Z,,2025-05-21T19:36:25Z,2025-08146,0,0,09000064b8d1fd35
FDA-2025-N-0002-0001,FDA,FDA-2025-N-0002,"New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug
Application; Change of Sponsor",Rule,Final Rule,2025-05-09T00:00:00Z,2025,5,2025-05-09T00:00:00Z,,2025-05-21T19:36:23Z,2025-08137,0,0,09000064b8d1ebb2
FDA-2025-N-0813-0001,FDA,FDA-2025-N-0813,"Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify
Microbial Nucleic Acids by Fluorescence In Situ Hybridization in Clinical Specimens",Rule,Final Rule,2025-05-09T00:00:00Z,2025,5,2025-05-09T00:00:00Z,,2025-05-21T19:36:25Z,2025-08150,0,0,09000064b8d1fdaf
FDA-2025-N-0780-0001,FDA,FDA-2025-N-0780,"Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Voriconazole Test
System",Rule,Final Rule,2025-05-09T00:00:00Z,2025,5,2025-05-09T00:00:00Z,,2025-05-21T19:36:26Z,2025-08148,0,0,09000064b8d1ec93
FDA-2025-N-0710-0001,FDA,FDA-2025-N-0710,Medical Devices; Immunology and Microbiology Devices; Classification of the Microbial Nucleic Acid Storage and Stabilization Device,Rule,Final Rule,2025-05-09T00:00:00Z,2025,5,2025-05-09T00:00:00Z,,2025-05-21T19:36:21Z,2025-08145,0,0,09000064b8d1ec8a
FDA-2025-N-0708-0001,FDA,FDA-2025-N-0708,"Medical Devices; Immunology and Microbiology Devices; Classification of the DNA-Based Test To Measure
Minimal Residual Disease in Hematological Malignancies",Rule,Final Rule,2025-05-09T00:00:00Z,2025,5,2025-05-09T00:00:00Z,,2025-05-21T19:36:21Z,2025-08143,0,0,09000064b8d1ec0d
FDA-2025-N-0711-0001,FDA,FDA-2025-N-0711,"Medical Devices; Hematology and Pathology Devices; Classification of the Coagulation System for the
Measurement of Whole Blood Viscoelastic Properties in Perioperative Patients",Rule,Final Rule,2025-05-09T00:00:00Z,2025,5,2025-05-09T00:00:00Z,,2025-05-21T19:36:24Z,2025-08151,0,0,09000064b8d1fe0d
FDA-2025-N-0814-0001,FDA,FDA-2025-N-0814,"Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect Nucleic Acids
From Non-Viral Microorganism(s) Causing Sexually Transmitted Infections and Associated Resistance Marker(s)",Rule,Final Rule,2025-05-09T00:00:00Z,2025,5,2025-05-09T00:00:00Z,,2025-05-21T19:36:23Z,2025-08149,0,0,09000064b8d1fe9d
FDA-2025-N-0831-0001,FDA,FDA-2025-N-0831,"Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Breast Milk
Macronutrients Test System",Rule,Final Rule,2025-05-09T00:00:00Z,2025,5,2025-05-09T00:00:00Z,,2025-05-21T19:36:21Z,2025-08147,0,0,09000064b8d1ec0b
FDA-2021-N-0862-0236,FDA,FDA-2021-N-0862,Nonprescription Drug Product With an Additional Condition for Nonprescription Use,Rule,Final Rule,2025-03-25T04:00:00Z,2025,3,,,2025-03-25T14:47:53Z,2025-04978,0,0,0900006486a2a7ed
FDA-2016-D-2335-1710,FDA,FDA-2016-D-2335,Food Labeling: Nutrient Content Claims; Definition of Term ‘‘Healthy’’,Rule,Delay of Effective Date,2025-02-25T05:00:00Z,2025,2,2025-02-25T05:00:00Z,,2025-02-25T13:16:44Z,2025-03118,0,0,090000648698e791
FDA-2021-N-0862-0235,FDA,FDA-2021-N-0862,Nonprescription Drug Product With an Additional Condition for Nonprescription Use,Rule,Final Rule,2025-01-27T05:00:00Z,2025,1,,,2025-01-27T14:30:42Z,2025-01840,0,0,0900006486900454
FDA-2024-N-0002-0004,FDA,FDA-2024-N-0002,"New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal
of Approval of New Animal Drug Applications; Change of Sponsor;
Change of Sponsor Address",Rule,Final Rule,2025-01-21T05:00:00Z,2025,1,2025-01-21T05:00:00Z,,2025-01-21T15:20:52Z,2025-01226,0,0,09000064868e3515
FDA-2022-C-0098-0002,FDA,FDA-2022-C-0098,Listing of Color Additives Exempt From Certification; Myoglobin,Rule,Final Rule,2025-01-17T05:00:00Z,2025,1,2025-01-17T05:00:00Z,2025-02-19T04:59:59Z,2025-01-23T13:45:03Z,2025-01239,0,0,09000064868e3163
FDA-2024-N-3654-0014,FDA,FDA-2024-N-3654,Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments; Withdrawal,Rule,Withdrawal,2025-01-17T05:00:00Z,2025,1,2025-01-17T05:00:00Z,,2025-01-21T14:32:52Z,2025-01145,0,0,09000064868e2fbb
FDA-2023-N-0437-34784,FDA,FDA-2023-N-0437,"Color Additive Petition From Center for Science in the Public Interest, et al.; Request To Revoke Color Additive Listing for Use of FD&C Red No. 3 in Food and Ingested Drugs",Rule,Final Rule,2025-01-16T05:00:00Z,2025,1,2025-01-16T05:00:00Z,2025-02-19T04:59:59Z,2025-02-21T02:00:44Z,2025-00830,0,0,09000064868c6612
FDA-2000-N-0011-0028,FDA,FDA-2000-N-0011,Uniform Compliance Date for Food Labeling Regulations,Rule,Final Rule,2024-12-31T05:00:00Z,2024,12,2024-12-31T05:00:00Z,2025-03-04T04:59:59Z,2025-03-05T02:00:44Z,2024-31419,0,0,0900006486896c8a
FDA-2016-D-2335-1702,FDA,FDA-2016-D-2335,"Food Labeling: Nutrient Content Claims; Definition of Term ""Healthy""",Rule,Final Rule,2024-12-27T05:00:00Z,2024,12,2024-12-27T05:00:00Z,,2024-12-27T16:48:15Z,2024-29957,0,0,0900006486891538
FDA-2021-N-0862-0207,FDA,FDA-2021-N-0862,Nonprescription Drug Product With an Additional Condition for Nonprescription Use,Rule,Final Rule,2024-12-26T05:00:00Z,2024,12,2024-12-26T05:00:00Z,,2024-12-26T15:41:32Z,2024-30261,0,0,090000648688bfbc
FDA-2024-N-0002-0003,FDA,FDA-2024-N-0002,"New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug
Applications; Change of Sponsor",Rule,Final Rule,2024-12-02T05:00:00Z,2024,12,2024-12-02T05:00:00Z,,2024-12-02T15:06:52Z,2024-28061,0,0,0900006486843dce
FDA-2022-N-1635-0018,FDA,FDA-2022-N-1635,Color Additive Certification; Increase in Fees for Certification Services,Rule,Final Rule,2024-11-08T05:00:00Z,2024,11,,,2024-11-08T13:57:22Z,2024-25974,0,0,09000064868092dc
FDA-2018-F-3757-0019,FDA,FDA-2018-F-3757,"Indirect Food Additives: Adhesives and Components of Coatings; Paper and Paperboard Components; Polymers; Adjuvants, Production Aids, and Sanitizers",Rule,Final Rule,2024-10-30T04:00:00Z,2024,10,2024-10-30T04:00:00Z,,2024-10-30T14:32:52Z,2024-25122,0,0,09000064867ebe98
FDA-2024-N-0002-0002,FDA,FDA-2024-N-0002,New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address,Rule,Final Rule,2024-10-28T04:00:00Z,2024,10,,,2024-10-28T12:53:21Z,2024-24820,0,0,09000064867e8d3a
FDA-2024-D-2977-0497,FDA,FDA-2024-D-2977,Food and Drug Administration Enforcement Policy for Association of American Feed Control Officials— Defined Animal Feed Ingredients; Guidance for Industry; Availability,Rule,Final Rule,2024-10-24T04:00:00Z,2024,10,2024-10-24T04:00:00Z,,2024-10-24T12:58:03Z,2024-24715,0,0,09000064867e1162
FDA-2024-N-3654-0005,FDA,FDA-2024-N-3654,Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments; Correction,Rule,Correction,2024-10-18T04:00:00Z,2024,10,2024-10-18T04:00:00Z,,2024-10-18T14:21:24Z,2024-24100,0,0,09000064867d6c0e
FDA-2021-N-0507-0087,FDA,FDA-2021-N-0507,Medical Devices; Quality System Regulation Amendments; Correction,Rule,Correction,2024-10-15T04:00:00Z,2024,10,,,2024-10-15T14:24:08Z,2024-23701,0,0,09000064867ce682
FDA-2016-N-2880-0007,FDA,FDA-2016-N-2880,"Microbiology Devices; Reclassification of Cytomegalovirus Deoxyribonucleic Acid Quantitative Assay Devices
Intended for Transplant Patient Management",Rule,Final Rule,2024-09-23T04:00:00Z,2024,9,2024-09-23T04:00:00Z,,2024-09-23T14:03:50Z,2024-21616,0,0,090000648676a027
FDA-2024-N-3654-0002,FDA,FDA-2024-N-3654,Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments,Rule,Direct Final Rule,2024-09-20T04:00:00Z,2024,9,2024-09-20T04:00:00Z,2024-12-05T04:59:59Z,2024-12-06T02:01:03Z,2024-21231,0,0,090000648675ecd8
FDA-2024-N-4084-0001,FDA,FDA-2024-N-4084,Medical Devices; Immunology and Microbiology Devices; Classification of the Quantitative Viral Nucleic Acid Test for Transplant Patient Management,Rule,Final Rule,2024-09-17T04:00:00Z,2024,9,2024-09-17T04:00:00Z,,2024-09-17T14:02:07Z,2024-21086,0,0,090000648672f697
FDA-2024-N-4082-0001,FDA,FDA-2024-N-4082,Medical Devices; Therapeutic Devices; Classification of the Pediatric Continuous Renal Replacement Therapy System,Rule,Final Rule,2024-09-16T04:00:00Z,2024,9,,,2024-09-16T14:27:25Z,2024-20999,0,0,0900006486722c9c
FDA-2024-N-4061-0001,FDA,FDA-2024-N-4061,Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect or Measure Nucleic Acid From Viruses Associated With Head and Neck Cancers,Rule,Final Rule,2024-09-16T04:00:00Z,2024,9,,,2024-09-16T14:36:22Z,2024-20896,0,0,0900006486722d0c
FDA-2024-N-4058-0001,FDA,FDA-2024-N-4058,Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Clozapine Test System,Rule,Final Rule,2024-09-16T04:00:00Z,2024,9,,,2024-09-16T14:51:24Z,2024-20895,0,0,0900006486722dad
FDA-2024-N-4018-0001,FDA,FDA-2024-N-4018,Medical Devices; Immunology and Microbiology Devices; Classification of the Whole Exome Sequencing Constituent Device,Rule,Final Rule,2024-09-11T04:00:00Z,2024,9,,,2024-09-11T13:13:44Z,2024-20550,0,0,09000064866e9441
FDA-2024-N-4059-0001,FDA,FDA-2024-N-4059,Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Pancreatic Debridement Device,Rule,Final Rule,2024-09-09T04:00:00Z,2024,9,2024-09-09T04:00:00Z,,2024-09-09T13:17:51Z,2024-20248,0,0,09000064866cf75f
FDA-2024-N-4086-0001,FDA,FDA-2024-N-4086,Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Blood Collection Device for Cell-Free Nucleic Acids,Rule,Final Rule,2024-09-09T04:00:00Z,2024,9,2024-09-09T04:00:00Z,,2024-09-09T13:20:12Z,2024-20254,0,0,09000064866cf859
FDA-2024-N-3972-0001,FDA,FDA-2024-N-3972,Medical Devices; Gastroenterology-Urology Devices; Classification of the Hemodialyzer With Expanded Solute Removal Profile,Rule,Final Rule,2024-09-06T04:00:00Z,2024,9,2024-09-06T04:00:00Z,,2024-09-06T14:54:33Z,2024-20081,0,0,09000064866caec3
FDA-2024-N-3947-0001,FDA,FDA-2024-N-3947,"Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Open Loop Fluid Therapy
Recommender",Rule,Final Rule,2024-09-05T04:00:00Z,2024,9,2024-09-05T04:00:00Z,,2024-09-05T13:16:15Z,2024-19736,0,0,09000064866c2b4a
FDA-2024-N-3973-0001,FDA,FDA-2024-N-3973,Medical Devices; Dental Devices; Classification of the Radiofrequency Toothbrush,Rule,Final Rule,2024-09-05T04:00:00Z,2024,9,2024-09-05T04:00:00Z,,2024-09-05T13:01:42Z,2024-19868,0,0,09000064866c29dc