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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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1,671 rows where agency_id = "FDA" and document_type = "Rule" sorted by posted_date descending

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  • FDA · 1,671 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
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