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| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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 | Uniform Compliance Date for Food Labeling Regulations 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 |
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