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

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58 rows where agency_id = "FDA", document_type = "Rule" and posted_year = 2021 sorted by posted_date descending

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posted_year 1

  • 2021 · 58 ✖

document_type 1

  • Rule · 58 ✖

agency_id 1

  • FDA · 58 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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 Regulation for establishing import tolerances 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 Revision of Yogurt Standards 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 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 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 Uniform Compliance Date for Food Labeling Regulations 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

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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);