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withdrawn,object_id FDA-2018-C-4117-0005,FDA,FDA-2018-C-4117,"Listing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract; Confirmation of Effective Date",Rule,Confirmation of Effective Date,2021-12-29T05:00:00Z,2021,12,2021-12-29T05:00:00Z,,2024-02-08T19:39:46Z,2021-28158,0,0,0900006484effc3e FDA-2018-C-4117-0004,FDA,FDA-2018-C-4117,"Listing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract; Confirmation of Effective Date",Rule,Final Rule,2021-12-29T05:00:00Z,2021,12,2021-12-29T05:00:00Z,,2024-02-08T19:39:30Z,2021-28159,0,0,0900006484effabc FDA-2021-N-0858-0001,FDA,FDA-2021-N-0858,"Medical Devices; Gastroenterology- Urology Devices; Classification of the Transcutaneous Electrical Continence Device",Rule,Final Rule,2021-12-29T05:00:00Z,2021,12,2021-12-29T05:00:00Z,,2021-12-29T17:27:03Z,2021-28163,0,0,0900006484effb9a FDA-2021-N-0573-0001,FDA,FDA-2021-N-0573,"Medical Devices; Neurological Devices; Classification of the Diagnostic Neurosurgical Microscope Filter",Rule,Final Rule,2021-12-29T05:00:00Z,2021,12,2021-12-29T05:00:00Z,,2021-12-29T17:27:59Z,2021-28160,0,0,0900006484effbf4 FDA-2021-N-0855-0001,FDA,FDA-2021-N-0855,"Medical Devices; Neurological Devices; Classification of the Cerebrospinal Fluid Shunt System",Rule,Final Rule,2021-12-29T05:00:00Z,2021,12,2021-12-29T05:00:00Z,,2021-12-29T17:26:25Z,2021-28157,0,0,0900006484effaf3 FDA-2021-N-0917-0001,FDA,FDA-2021-N-0917,"Medical Devices; Anesthesiology Devices; Classification of the Retrograde Intubation Device",Rule,Final Rule,2021-12-28T05:00:00Z,2021,12,2021-12-28T05:00:00Z,,2021-12-28T17:42:04Z,2021-28166,0,0,0900006484efed3f FDA-2021-N-0857-0001,FDA,FDA-2021-N-0857,"Medical Devices; General and Plastic Surgery Devices; Classification of the Manual Percutaneous Surgical Set Assembled in the Abdomen",Rule,Final Rule,2021-12-17T05:00:00Z,2021,12,2021-12-17T05:00:00Z,,2021-12-21T20:01:33Z,2021-27317,0,0,0900006484ed1e64 FDA-2021-N-0896-0001,FDA,FDA-2021-N-0896,Medical Devices; Neurological Devices; Classification of the Traumatic Brain Injury Eye Movement Assessment Aid,Rule,Final Rule,2021-12-16T05:00:00Z,2021,12,2021-12-16T05:00:00Z,,2021-12-16T15:19:44Z,2021-27227,0,0,0900006484ecfb05 FDA-2021-N-0583-0001,FDA,FDA-2021-N-0583,"Medical Devices; Gastroenterology- Urology Devices; Classification of the Nonimplanted Nerve Stimulator for Functional Abdominal Pain Relief",Rule,Final Rule,2021-12-15T05:00:00Z,2021,12,2021-12-15T05:00:00Z,,2021-12-15T16:16:01Z,2021-27132,0,0,0900006484ecaef9 FDA-2021-N-0590-0001,FDA,FDA-2021-N-0590,"Medical Devices; Gastroenterology- Urology Devices; Classification of the Endoscopic Transhepatic Venous Access Needle",Rule,Final Rule,2021-12-15T05:00:00Z,2021,12,2021-12-15T05:00:00Z,,2021-12-15T16:15:11Z,2021-27135,0,0,0900006484ecae9c FDA-2021-N-0898-0001,FDA,FDA-2021-N-0898,Medical Devices; Gastroenterology-Urology Devices; Classification of the Pressure Ulcer Management Tool,Rule,Final Rule,2021-12-13T05:00:00Z,2021,12,2021-12-13T05:00:00Z,,2021-12-13T14:21:04Z,2021-26924,0,0,0900006484ec08ac FDA-2021-N-0575-0001,FDA,FDA-2021-N-0575,Medical Devices; Neurological Devices; Classification of the Temporary Coil Embolization Assist Device,Rule,Final Rule,2021-12-13T05:00:00Z,2021,12,2021-12-13T05:00:00Z,,2021-12-13T14:12:28Z,2021-26926,0,0,0900006484ec0865 FDA-2021-N-0572-0001,FDA,FDA-2021-N-0572,"Medical Devices; General and Plastic Surgery Devices; Classification of the Negative Pressure Wound Therapy Device for Reduction of Wound Complications",Rule,Final Rule,2021-12-10T05:00:00Z,2021,12,2021-12-10T05:00:00Z,,2021-12-10T15:02:42Z,2021-26741,0,0,0900006484eb80bc FDA-2021-N-0585-0001,FDA,FDA-2021-N-0585,"Medical Devices; Gastroenterology-Urology Devices; Classification of the Ingested, Transient, Space Occupying Device for Weight Management and/or Weight Loss",Rule,Final Rule,2021-12-10T05:00:00Z,2021,12,2021-12-10T05:00:00Z,,2021-12-10T14:34:02Z,2021-26738,0,0,0900006484eb7ff4 FDA-2021-N-0595-0001,FDA,FDA-2021-N-0595,"Medical Devices; Neurological Devices; Classification of the Transcutaneous Electrical Nerve Stimulator for Attention Deficit Hyperactivity Disorder",Rule,Final Rule,2021-12-10T05:00:00Z,2021,12,2021-12-10T05:00:00Z,,2021-12-10T14:39:25Z,2021-26740,0,0,0900006484eb80b9 FDA-2019-N-3065-0878,FDA,FDA-2019-N-3065,Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Delayed Effective Date,Rule,Delay of Effective Date,2021-12-09T05:00:00Z,2021,12,2021-12-09T05:00:00Z,,2021-12-09T14:21:52Z,2021-26643,0,0,0900006484eb2301 FDA-2021-P-0424-0007,FDA,FDA-2021-P-0424,"Medical Devices; Exemption From Premarket Notification: Powered Patient Transport, All Other Powered Patient Transport",Rule,Final Rule,2021-12-08T05:00:00Z,2021,12,2021-12-08T05:00:00Z,,2021-12-08T14:03:54Z,2021-26636,0,0,0900006484eaede6 FDA-2019-N-3325-0124,FDA,FDA-2019-N-3325,Laboratory Accreditation for Analyses of Foods,Rule,Final Rule,2021-12-03T05:00:00Z,2021,12,2021-12-03T05:00:00Z,,2021-12-03T16:37:13Z,2021-25716,0,0,0900006484e9c71c FDA-2021-N-0261-0001,FDA,FDA-2021-N-0261,Medical Devices; Neurological Devices; Classification of the Trunk and Limb Electrical Stimulator To Treat Headache,Rule,Final Rule,2021-12-02T05:00:00Z,2021,12,2021-12-02T05:00:00Z,,2021-12-02T19:09:34Z,2021-26175,0,0,0900006484e9360d FDA-2021-N-0622-0001,FDA,FDA-2021-N-0622,Medical Devices; Anesthesiology Devices; Classification of the Isocapnic Ventilation Device,Rule,Final Rule,2021-12-02T05:00:00Z,2021,12,2021-12-02T05:00:00Z,,2021-12-02T19:04:51Z,2021-26201,0,0,0900006484e935d6 FDA-2021-N-0290-0001,FDA,FDA-2021-N-0290,Medical Devices; Neurological Devices; Classification of the Conditioning Tool for Eating Disorders,Rule,Final Rule,2021-12-02T05:00:00Z,2021,12,2021-12-02T05:00:00Z,,2021-12-02T19:14:44Z,2021-26176,0,0,0900006484e9360f FDA-2021-N-0648-0001,FDA,FDA-2021-N-0648,"Medical Devices; Orthopedic Devices; Classification of the Intraoperative Orthopedic Strain Sensor",Rule,Final Rule,2021-12-02T05:00:00Z,2021,12,2021-12-02T05:00:00Z,,2021-12-02T16:48:33Z,2021-26183,0,0,0900006484e93613 FDA-2021-N-0285-0001,FDA,FDA-2021-N-0285,Medical Devices; Gastroenterology- Urology Devices; Classification of the Esophageal Tissue Characterization System,Rule,Final Rule,2021-12-02T05:00:00Z,2021,12,2021-12-02T05:00:00Z,,2021-12-02T19:26:34Z,2021-26200,0,0,0900006484e9372d FDA-2018-N-1913-0001,FDA,FDA-2018-N-1913,Medical Devices; General and Plastic Surgery Devices; Classification of the General Laparoscopic Power Morcellation Containment System,Rule,Final Rule,2021-11-23T05:00:00Z,2021,11,2021-11-23T05:00:00Z,,2021-11-23T15:02:19Z,2021-25585,0,0,0900006484e7590e FDA-2016-N-0400-0191,FDA,FDA-2016-N-0400,Medical Devices; General and Plastic Surgery Devices; Reclassification of Blood Lancets,Rule,Final Rule,2021-11-22T05:00:00Z,2021,11,2021-11-22T05:00:00Z,,2021-11-22T15:51:30Z,2021-25376,0,0,0900006484e71279 FDA-2016-M-0035-0045,FDA,FDA-2016-M-0035,"Effective Date of Requirement for Premarket Approval for Blood Lancets",Rule,Final Rule,2021-11-22T05:00:00Z,2021,11,2021-11-22T05:00:00Z,,2021-11-22T15:54:18Z,2021-25381,0,0,0900006484e71390 FDA-2020-N-1088-0014,FDA,FDA-2020-N-1088,"Microbiology Devices; Reclassification of Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Assay Devices, Renamed to Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Tests",Rule,Final Rule,2021-11-22T05:00:00Z,2021,11,2021-11-22T05:00:00Z,,2021-11-22T15:44:54Z,2021-25379,0,0,0900006484e71238 FDA-2020-N-1082-0018,FDA,FDA-2020-N-1082,"Microbiology Devices; Reclassification of Certain Hepatitis C Virus Antibody Assay Devices, Renamed to Hepatitis C Virus Antibody Tests",Rule,Final Rule,2021-11-22T05:00:00Z,2021,11,2021-11-22T05:00:00Z,,2021-11-22T15:48:14Z,2021-25374,0,0,0900006484e71277 FDA-2021-N-0002-0024,FDA,FDA-2021-N-0002,New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsor Address,Rule,Final Rule,2021-11-08T05:00:00Z,2021,11,2021-11-08T05:00:00Z,,2021-11-08T14:01:16Z,2021-24075,0,0,0900006484e35459 FDA-2021-N-0002-0001,FDA,FDA-2021-N-0002,New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship,Rule,Final Rule,2021-10-20T04:00:00Z,2021,10,2021-10-20T04:00:00Z,,2021-10-20T15:15:02Z,2021-22604,0,0,0900006484dcea30 FDA-2019-N-1250-0009,FDA,FDA-2019-N-1250,General and Plastic Surgery Devices; Reclassification of Certain Surgical Staplers,Rule,Final Rule,2021-10-08T04:00:00Z,2021,10,2021-10-08T04:00:00Z,,2021-10-15T14:13:19Z,2021-22041,0,0,0900006484dbf9b9 FDA-2017-C-1951-0235,FDA,FDA-2017-C-1951,"Termination of Listing of Color Additives Exempt From Certification; Lead Acetate",Rule,Final Rule,2021-10-08T04:00:00Z,2021,10,2021-10-08T04:00:00Z,,2021-10-08T13:20:08Z,2021-21892,0,0,0900006484dbf0c6 FDA-2018-C-0617-0006,FDA,FDA-2018-C-0617,Listing of Color Additives Exempt From Certification; Silver Nitrate,Rule,Final Rule,2021-10-06T04:00:00Z,2021,10,2021-10-06T04:00:00Z,2021-11-06T03:59:59Z,2021-11-05T01:01:00Z,2021-21755,0,0,0900006484dbc6b8 FDA-2016-N-3818-0176,FDA,FDA-2016-N-3818,Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports,Rule,Final Rule,2021-10-05T04:00:00Z,2021,10,2021-10-05T04:00:00Z,,2021-10-05T20:23:28Z,2021-21009,0,0,0900006484dba96e FDA-2018-N-0236-0028,FDA,FDA-2018-N-0236,Medical Device De Novo Classification Process,Rule,Final Rule,2021-10-05T04:00:00Z,2021,10,2021-10-05T04:00:00Z,,2021-10-05T16:21:46Z,2021-21677,0,0,0900006484dbaa56 FDA-2019-N-2854-1147,FDA,FDA-2019-N-2854,"Premarket Tobacco Product Applications and Recordkeeping Requirements",Rule,Final Rule,2021-10-05T04:00:00Z,2021,10,2021-10-05T04:00:00Z,,2021-10-05T20:22:52Z,2021-21011,0,0,0900006484dba972 FDA-2001-N-0075-0027,FDA,FDA-2001-N-0075,"Import Tolerances for Residues of Unapproved New Animal Drugs in Food",Rule,Final Rule,2021-09-21T04:00:00Z,2021,9,2021-09-21T04:00:00Z,2021-10-22T03:59:59Z,2021-10-22T01:01:24Z,2021-19967,0,0,0900006484d98dbf FDA-2019-N-3065-0877,FDA,FDA-2019-N-3065,Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Delayed Effective Date,Rule,Delay of Effective Date,2021-09-13T04:00:00Z,2021,9,2021-09-13T04:00:00Z,,2022-06-01T13:02:06Z,2021-19688,0,0,0900006484d75ac6 FDA-2021-N-0011-0001,FDA,FDA-2021-N-0011,Revision to Restrictions on Shipment or Use for Human Blood and Blood Components Exceptions; Technical Amendment,Rule,Final Rule,2021-09-07T04:00:00Z,2021,9,2021-09-07T04:00:00Z,,2021-09-07T13:10:03Z,2021-19220,0,0,0900006484d56736 FDA-2018-C-4117-0002,FDA,FDA-2018-C-4117,Listing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract,Rule,Final Rule,2021-09-02T04:00:00Z,2021,9,2021-09-02T04:00:00Z,2021-10-05T03:59:59Z,2024-02-08T19:39:13Z,2021-18995,0,0,0900006484d43741 FDA-2015-N-2002-2054,FDA,FDA-2015-N-2002,Regulations Regarding ‘‘Intended Uses’’,Rule,Final Rule,2021-08-02T04:00:00Z,2021,8,2021-08-02T04:00:00Z,,2021-08-02T16:56:29Z,2021-15980,0,0,0900006484c2027a FDA-2020-F-1289-0002,FDA,FDA-2020-F-1289,Food Additives Permitted in Feed and Drinking Water of Animals; Selenomethionine Hydroxy Analogue,Rule,Final Rule,2021-07-14T04:00:00Z,2021,7,2021-07-14T04:00:00Z,2021-08-14T03:59:59Z,2021-07-20T17:26:00Z,2021-15072,0,0,0900006484befa85 FDA-2019-F-5401-0002,FDA,FDA-2019-F-5401,Food Additives Permitted in Feed and Drinking Water of Animals; Guanidinoacetic Acid,Rule,Final Rule,2021-07-14T04:00:00Z,2021,7,2021-07-14T04:00:00Z,2021-08-14T03:59:59Z,2021-07-15T01:00:26Z,2021-15070,0,0,0900006484befa35 FDA-2019-N-3065-0876,FDA,FDA-2019-N-3065,Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Delayed Effective Date,Rule,Delay of Effective Date,2021-07-12T04:00:00Z,2021,7,2021-07-12T04:00:00Z,,2021-07-12T15:35:12Z,2021-14678,0,0,0900006484be4280 FDA-2000-P-0126-0096,FDA,FDA-2000-P-0126,"Milk and Cream Products and Yogurt Products; Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for Yogurt",Rule,Final Rule,2021-06-11T04:00:00Z,2021,6,2021-06-11T04:00:00Z,2021-07-13T03:59:59Z,2023-05-19T12:29:26Z,2021-12220,0,0,0900006484b6bc96 FDA-2018-N-1440-0001,FDA,FDA-2018-N-1440,Medical Devices; Medical Device Classification Regulations To Conform to Medical Software Provisions in the 21st Century Cures Act,Rule,Final Rule,2021-04-19T04:00:00Z,2021,4,2021-04-19T04:00:00Z,,2021-04-19T18:10:31Z,2021-07860,0,0,0900006484aab448 FDA-2021-N-0246-0001,FDA,FDA-2021-N-0246,Medical Devices; Technical Amendments,Rule,Final Rule,2021-04-01T04:00:00Z,2021,4,2021-04-01T04:00:00Z,,2023-03-21T15:12:01Z,2021-06681,0,0,0900006484a9351a FDA-2016-N-1487-0024,FDA,FDA-2016-N-1487,Electronic Import Entries; Technical Amendments,Rule,Final Rule,2021-04-01T04:00:00Z,2021,4,2021-04-01T04:00:00Z,,2021-04-01T17:01:37Z,2021-06679,0,0,0900006484a92f39 FDA-2005-N-0464-0249,FDA,FDA-2005-N-0464,"Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs; Corrections",Rule,Final Rule,2021-04-01T04:00:00Z,2021,4,2021-04-01T04:00:00Z,,2021-04-01T15:35:43Z,2021-06677,0,0,0900006484a93032 FDA-2020-N-0002-0025,FDA,FDA-2020-N-0002,New Animal Drugs; Approval of New Animal Drug Applications,Rule,Final Rule,2021-04-01T04:00:00Z,2021,4,2021-04-01T04:00:00Z,,2021-04-01T16:02:40Z,2021-06704,0,0,0900006484a930d8 FDA-2021-N-0009-0059,FDA,FDA-2021-N-0009,"Securing Updated and Necessary Statutory Evaluations Timely; Administrative Delay of Effective Date; Correction",Rule,Delay of Effective Date,2021-03-23T04:00:00Z,2021,3,2021-03-23T04:00:00Z,,2021-03-23T14:00:55Z,2021-05907,0,0,0900006484a75364 FDA-2020-N-0002-0024,FDA,FDA-2020-N-0002,"New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Change of Sponsor’s Name and Address",Rule,Final Rule,2021-03-19T04:00:00Z,2021,3,2021-03-19T04:00:00Z,,2021-03-19T12:43:17Z,2021-05203,0,0,0900006484a71970 FDA-2020-N-0002-0011,FDA,FDA-2020-N-0002,New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor,Rule,Final Rule,2021-03-08T05:00:00Z,2021,3,2021-03-08T05:00:00Z,,2021-03-08T13:45:25Z,2021-04453,0,0,0900006484a629fd FDA-2019-N-5405-0004,FDA,FDA-2019-N-5405,New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications,Rule,Withdrawal,2021-02-23T05:00:00Z,2021,2,2021-02-23T05:00:00Z,,2021-02-23T14:13:24Z,2021-03250,0,0,0900006484a48841 FDA-2019-N-5405-0005,FDA,FDA-2019-N-5405,New Animal Drug Applications; BetaAminopropionitrile Fumarate; n-Butyl Chloride; Cupric Glycinate Injection; Dichlorophene and Toluene; Orgotein for Injection; Tetracycline Tablets,Rule,Final Rule,2021-02-23T05:00:00Z,2021,2,2021-02-23T05:00:00Z,,2021-02-23T15:22:10Z,2021-03251,0,0,0900006484a48d27 FDA-2021-Z-0025-0001,FDA,FDA-2021-Z-0025,Securing Updated and Necessary Statutory Evaluations Timely,Rule,Final Rule,2021-01-19T05:00:00Z,2021,1,2021-01-19T05:00:00Z,,2021-01-21T17:14:56Z,2021-00597,0,0,09000064849f7f15 FDA-2019-N-3065-0875,FDA,FDA-2019-N-3065,Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Delayed Effective Date,Rule,Delay of Effective Date,2021-01-15T05:00:00Z,2021,1,2021-01-15T05:00:00Z,,2022-06-01T13:03:09Z,2021-00703,0,0,09000064849f4757 FDA-2000-N-0011-0020,FDA,FDA-2000-N-0011,Uniform Compliance Date for Food Labeling Regulations,Rule,Final Rule,2021-01-06T05:00:00Z,2021,1,2021-01-06T05:00:00Z,2021-03-09T04:59:59Z,2021-03-09T02:00:28Z,2020-29273,0,0,09000064849e0939