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

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

56 rows where agency_id = "FDA", document_type = "Rule" and posted_year = 2023 sorted by posted_date descending

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  • 2023 · 56 ✖

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  • Rule · 56 ✖

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  • FDA · 56 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2009-N-0582-0130 FDA FDA-2009-N-0582 Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule: Questions and Answers; Guidance for Industry; Small Entity Compliance Guide; Availability Rule Final Rule with Request for Comments 2023-12-27T05:00:00Z 2023 12 2023-12-27T05:00:00Z   2023-12-27T14:34:36Z 2023-28530 0 0 090000648635c371
FDA-2018-N-2727-0051 FDA FDA-2018-N-2727 Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations Rule Direct Final Rule 2023-12-21T05:00:00Z 2023 12 2023-12-21T05:00:00Z   2023-12-21T15:50:35Z 2023-27935 0 0 090000648634dce5
FDA-2020-F-0151-0002 FDA FDA-2020-F-0151 Food Additives Permitted in Feed and Drinking Water of Animals; Calcium Formate Rule Final Rule 2023-12-19T05:00:00Z 2023 12 2023-12-19T05:00:00Z 2024-01-19T04:59:59Z 2024-01-19T02:00:13Z 2023-27857 0 0 0900006486346a65
FDA-2019-N-4750-0040 FDA FDA-2019-N-4750 Revocation of Uses of Partially Hydrogenated Oils in Foods; Confirmation of Effective Date Rule Direct Final Rule 2023-12-14T05:00:00Z 2023 12     2023-12-14T14:33:02Z 2023-27506 0 0 0900006486339a44
FDA-2023-N-0002-0031 FDA FDA-2023-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 2023-12-06T05:00:00Z 2023 12 2023-12-06T05:00:00Z   2024-05-06T12:04:48Z 2023-26545 0 0 09000064862ff365
FDA-2023-D-4722-0001 FDA FDA-2023-D-4722 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; Small Entity Compliance Guide; Availability Rule Direct Final Rule 2023-11-28T05:00:00Z 2023 11 2023-11-28T05:00:00Z   2024-11-12T06:23:19Z 2023-26095 1 0 09000064862bc465
FDA-2009-N-0582-0061 FDA FDA-2009-N-0582 Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Rule Direct Final Rule 2023-11-21T05:00:00Z 2023 11 2023-11-21T05:00:00Z   2024-01-05T14:03:16Z 2023-25428 0 0 090000648629f6eb
FDA-2023-N-4487-0001 FDA FDA-2023-N-4487 Medical Devices; Hematology and Pathology Devices; Classification of the Container System for the Processing and Storage of Red Blood Cell Components Reduced Oxygen Condition Rule Direct Final Rule 2023-11-09T05:00:00Z 2023 11 2023-11-09T05:00:00Z   2023-11-09T14:55:24Z 2023-24717 0 0 0900006486232116
FDA-2020-C-2131-0006 FDA FDA-2020-C-2131 Listing of Color Additives Exempt From Certification; Jagua (Genipin-Glycine) Blue Rule Direct Final Rule 2023-11-03T04:00:00Z 2023 11 2023-11-03T04:00:00Z 2023-12-05T04:59:59Z 2023-12-02T02:01:28Z 2023-24352 0 0 09000064861dfb35
FDA-2022-D-0588-0012 FDA FDA-2022-D-0588 Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements; Guidance for Industry; Availability. Rule Final Rule 2023-10-18T04:00:00Z 2023 10 2023-10-18T04:00:00Z   2023-10-19T13:45:19Z 2023-22957 0 0 090000648610438b
FDA-2011-N-0179-0032 FDA FDA-2011-N-0179 Prior Notice of Imported Food Questions and Answers (Edition 4): Guidance for Industry; Availability Rule Approval 2023-10-13T04:00:00Z 2023 10 2023-10-13T04:00:00Z   2026-02-25T18:51:36Z 2023-22649 0 0 09000064860cde7c
FDA-2014-N-0053-1327 FDA FDA-2014-N-0053 Requirements for Additional Traceability Records for Certain Foods; Technical Amendment Rule Final Rule 2023-09-26T04:00:00Z 2023 9 2023-09-26T04:00:00Z   2023-09-26T14:20:20Z 2023-20746 0 0 0900006485ff576c
FDA-2023-N-3497-0001 FDA FDA-2023-N-3497 Advisory Committee; Board of Tea Experts; Termination and Technical Amendment to the Citation for the Federal Advisory Committee Act Rule Final Rule 2023-09-19T04:00:00Z 2023 9 2023-09-19T04:00:00Z   2023-09-19T17:00:30Z 2023-20012 0 0 0900006485fcf75a
FDA-2019-D-4212-0008 FDA FDA-2019-D-4212 Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies, Revision 1; Guidance for Industry; Availability Rule Final Rule 2023-09-01T04:00:00Z 2023 9 2023-09-01T04:00:00Z   2023-09-05T13:17:12Z 2023-18899 0 0 0900006485f2ff32
FDA-2023-D-1909-0001 FDA FDA-2023-D-1909 Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act—Compliance Policies; Guidance for Industry; Availability Rule Advance Notice of Proposed Rulemaking (ANPRM) 2023-08-28T04:00:00Z 2023 8     2023-08-28T14:19:12Z 2023-18359 0 0 0900006485f00191
FDA-2023-N-0002-0020 FDA FDA-2023-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 2023-08-16T04:00:00Z 2023 8 2023-08-16T04:00:00Z   2023-08-16T13:52:41Z 2023-17454 0 0 0900006485e5693b
FDA-2019-N-4750-0002 FDA FDA-2019-N-4750 Revocation of Uses of Partially Hydrogenated Oils in Foods Rule Direct Final Rule 2023-08-09T04:00:00Z 2023 8 2023-08-09T04:00:00Z 2023-10-24T03:59:59Z 2023-10-24T01:03:03Z 2023-16725 0 0 0900006485e047f1
FDA-2023-N-0963-0001 FDA FDA-2023-N-0963 Nomenclature Change for Dockets Management; Technical Amendment Rule Final Rule 2023-07-14T04:00:00Z 2023 7 2023-07-14T04:00:00Z   2023-07-14T12:59:25Z 2023-14716 0 0 0900006485cb1ad7
FDA-2022-N-2898-0002 FDA FDA-2022-N-2898 Food Labeling, Infant Formula Requirements, Food Additives and Generally Recognized as Safe Substances, New Dietary Ingredient Notification; Technical Amendments; Correction Rule Correction 2023-05-24T04:00:00Z 2023 5 2023-05-24T04:00:00Z   2023-05-24T13:02:04Z 2023-10602 0 0 0900006485a42615
FDA-2023-D-1336-0001 FDA FDA-2023-D-1336 Requirements for Additional Traceability Records for Certain Foods: What You Need To Know About the Food and Drug Administration Regulation: Guidance for Industry; Small Entity Compliance Guide; Availability Rule Final Rule with Request for Comments 2023-05-19T04:00:00Z 2023 5 2023-05-19T04:00:00Z   2023-05-19T15:03:32Z 2023-10666 0 0 0900006485a22b55
FDA-2000-P-0126-0135 FDA Revision of Yogurt Standards FDA-2000-P-0126 International Dairy Foods Association: Response to the Objections and Requests for a Public Hearing on the Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and Amend the Standard for Yogurt; Correction Rule Correction 2023-05-18T04:00:00Z 2023 5 2023-05-18T04:00:00Z   2023-05-19T12:32:00Z 2023-10606 0 0 0900006485a1c5f8
FDA-2023-N-0002-0001 FDA FDA-2023-N-0002 New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications Rule Final Rule 2023-05-03T04:00:00Z 2023 5 2023-05-03T04:00:00Z   2023-05-03T20:15:01Z 2023-09212 0 0 09000064859c163d
FDA-2000-P-0126-0132 FDA Revision of Yogurt Standards FDA-2000-P-0126 International Dairy Foods Association: Response to the Objections and Requests for a Public Hearing on the Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and Amend the Standard for Yogurt Rule Final Rule 2023-04-14T04:00:00Z 2023 4 2023-04-14T04:00:00Z 2023-05-16T03:59:59Z 2023-05-19T12:31:03Z 2023-07723 0 0 0900006485948f89
FDA-2021-N-0310-0016 FDA FDA-2021-N-0310 Medical Devices; Orthopedic Devices; Classification of Spinal Spheres for Use in Intervertebral Fusion Proceduress Rule Final Rule 2023-03-30T04:00:00Z 2023 3 2023-03-30T04:00:00Z   2023-03-30T17:41:43Z 2023-06566 0 0 090000648588ded2
FDA-2021-N-0310-0015 FDA FDA-2021-N-0310 Medical Devices; Orthopedic Devices; Classification of Spinal Spheres for Use in Intervertebral Fusion Procedures Rule Final Rule 2023-03-30T04:00:00Z 2023 3 2023-03-30T04:00:00Z   2023-04-10T14:30:06Z 2023-06566 0 0 0900006485892feb
FDA-2021-N-0309-0017 FDA FDA-2021-N-0309 Effective Date of Requirement for Premarket Approval Applications for Spinal Spheres for Use in Intervertebral Fusion Procedure Rule Advance Notice of Proposed Rulemaking (ANPRM) 2023-03-30T04:00:00Z 2023 3 2023-03-30T04:00:00Z   2023-03-30T17:12:14Z 2023-06565 0 0 0900006485892ecc
FDA-2023-N-0986-0001 FDA FDA-2023-N-0986 Change of Address; Technical Amendment Rule Final Rule 2023-03-27T04:00:00Z 2023 3 2023-03-27T04:00:00Z   2023-03-27T14:54:15Z 2023-06260 0 0 090000648586903b
FDA-2022-N-2898-0001 FDA FDA-2022-N-2898 Food Labeling, Infant Formula Requirements, Food Additives and Generally Recognized as Safe Substances, New Dietary Ingredient Notification; Technical Amendments Rule Final Rule 2023-03-24T04:00:00Z 2023 3 2023-03-24T04:00:00Z   2023-03-24T13:16:08Z 2023-05418 0 0 0900006485840a4c
FDA-2022-N-3262-0001 FDA FDA-2022-N-3262 Definition of the Term ``Tobacco Product'' in Regulations Issued Under the Federal Food, Drug, and Cosmetic Act Rule Technical Amendment 2023-03-24T04:00:00Z 2023 3 2023-03-24T04:00:00Z   2023-04-18T13:38:07Z 2023-03950 0 0 09000064857fde1c
FDA-2021-N-0246-0003 FDA FDA-2021-N-0246 Medical Devices; Technical Amendments Rule Final Rule 2023-03-21T04:00:00Z 2023 3 2023-03-21T04:00:00Z   2023-03-21T15:12:27Z 2023-05657 0 0 090000648580f43d
FDA-2022-N-0002-0050 FDA FDA-2022-N-0002 New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor Rule Final Rule 2023-03-20T04:00:00Z 2023 3 2023-03-20T04:00:00Z   2023-03-20T13:29:00Z 2023-05465 0 0 09000064857fdf5e
FDA-2020-C-1309-0013 FDA FDA-2020-C-1309 Listing of Color Additives Exempt From Certification; Spirulina Extract; Confirmation of Effective Date Rule Final Rule 2023-03-16T04:00:00Z 2023 3 2023-03-16T04:00:00Z   2023-03-16T15:23:40Z 2023-05361 0 0 09000064857b8ed7
FDA-2013-N-0134-0190 FDA FDA-2013-N-0134 Mammography Quality Standards Act Rule Final Rule 2023-03-10T05:00:00Z 2023 3 2023-03-10T05:00:00Z   2023-03-20T17:55:37Z 2023-04550 0 0 090000648578c535
FDA-2022-N-0002-0039 FDA FDA-2022-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 Name and Address Rule Final Rule 2023-03-10T05:00:00Z 2023 3 2023-03-10T05:00:00Z   2023-03-10T14:16:10Z 2023-03649 0 0 090000648578b486
FDA-2019-N-0646-0002 FDA FDA-2019-N-0646 Change of Address; Technical Amendment Rule Final Rule 2023-03-02T05:00:00Z 2023 3 2023-03-02T05:00:00Z   2023-03-02T14:34:58Z 2023-04010 0 0 090000648573e18d
FDA-2023-N-0062-0001 FDA FDA-2023-N-0062 Medical Devices; Hematology and Pathology Devices; Classification of the Software Algorithm Device To Assist Users in Digital Pathology Rule Final Rule 2023-02-02T05:00:00Z 2023 2 2023-02-02T05:00:00Z   2023-02-02T14:40:06Z 2023-02141 0 0 090000648562c147
FDA-2014-N-0053-1325 FDA FDA-2014-N-0053 Requirements for Additional Traceability Records for Certain Foods - Correction Rule Correction 2023-02-01T05:00:00Z 2023 2 2023-02-01T05:00:00Z   2023-09-26T14:20:06Z C1-2022-24417 0 0 09000064856258ea
FDA-2023-N-0091-0001 FDA FDA-2023-N-0091 Medical Devices; Cardiovascular Devices; Classification of the Software for Optical Camera-Based Measurement of Pulse Rate, Heart Rate, Breathing Rate, and/or Respiratory Rate Rule Final Rule 2023-01-31T05:00:00Z 2023 1 2023-01-31T05:00:00Z   2023-01-31T13:44:50Z 2023-01967 0 0 090000648561eefa
FDA-2017-C-6238-0017 FDA FDA-2017-C-6238 Listing of Color Additives Exempt From Certification; Calcium Carbonate; Confirmation of Effective Date Rule Confirmation of Effective Date 2023-01-24T05:00:00Z 2023 1 2023-01-24T05:00:00Z   2023-01-24T17:02:47Z 2023-01185 0 0 0900006485606020
FDA-2011-N-0583-0016 FDA FDA-2011-N-0583 Clarification of Orphan-Drug Exclusivity Following Catalyst Pharms., Inc. v. Becerra; Notification Rule Approval 2023-01-24T05:00:00Z 2023 1 2023-01-24T05:00:00Z   2023-01-24T17:14:45Z 2023-01179 0 0 0900006485606066
FDA-2022-N-3255-0001 FDA FDA-2022-N-3255 Medical Devices; Gastroenterology-Urology Devices; Classification of the Computerized Behavioral Therapy Device for Treating Symptoms of Gastrointestinal Conditions Rule Final Rule 2023-01-20T05:00:00Z 2023 1 2023-01-20T05:00:00Z   2023-01-20T16:22:34Z 2023-01048 0 0 09000064855fbdb3
FDA-2018-N-3303-0022 FDA FDA-2018-N-3303 Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-ray, Laser, and Ultrasonic Products Rule Final Rule 2023-01-20T05:00:00Z 2023 1 2023-01-20T05:00:00Z   2023-05-04T16:31:12Z 2023-00922 0 0 09000064855fb48e
FDA-2022-N-3256-0001 FDA FDA-2022-N-3256 Medical Devices; Ophthalmic Devices; Classification of the Intense Pulsed Light Device for Managing Dry Eye Rule Final Rule 2023-01-20T05:00:00Z 2023 1 2023-01-20T05:00:00Z   2023-01-20T14:52:23Z 2023-01049 0 0 09000064855fbd7e
FDA-2022-N-3335-0001 FDA FDA-2022-N-3335 Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Prognostic Test for Assessment of Liver Related Disease Progression Rule Final Rule 2023-01-17T05:00:00Z 2023 1 2023-01-17T05:00:00Z   2023-01-17T13:45:34Z 2023-00480 0 0 09000064855f0e08
FDA-2022-N-3240-0001 FDA FDA-2022-N-3240 Medical Devices; Neurological Devices; Classification of the Digital Therapy Device To Reduce Sleep Disturbance for Psychiatric Conditions Rule Final Rule 2023-01-13T05:00:00Z 2023 1 2023-01-13T05:00:00Z   2023-01-13T13:20:40Z 2023-00497 0 0 09000064855eba3f
FDA-2022-N-3171-0001 FDA FDA-2022-N-3171 Medical Devices; Ear, Nose, and Throat Devices; Classification of the Powered Insertion System for a Cochlear Implant Electrode Array Rule Final Rule 2023-01-06T05:00:00Z 2023 1 2023-01-06T05:00:00Z   2023-01-06T13:29:39Z 2023-00008 0 0 090000648559b1a3
FDA-2022-N-3189-0001 FDA FDA-2022-N-3189 Medical Devices; Cardiovascular Devices; Classification of the Hardware and Software for Optical Camera-Based Measurement of Pulse Rate, Heart Rate, Breathing Rate, and/ or Respiratory Rate Rule Final Rule 2023-01-06T05:00:00Z 2023 1 2023-01-06T05:00:00Z   2023-01-06T14:21:43Z 2023-00010 0 0 090000648559b260
FDA-2022-N-3131-0001 FDA FDA-2022-N-3131 Medical Devices; Physical Medicine Devices; Classification of the Electroencephalography-Driven Upper Extremity Powered Exerciser Rule Final Rule 2023-01-06T05:00:00Z 2023 1 2023-01-06T05:00:00Z   2023-01-06T14:27:43Z 2023-00007 0 0 090000648559b2a5
FDA-2022-N-3190-0001 FDA FDA-2022-N-3190 Medical Devices; Orthopedic Devices; Classification of the Resorbable Shoulder Spacer Rule Final Rule 2023-01-06T05:00:00Z 2023 1 2023-01-06T05:00:00Z   2023-01-06T14:16:33Z 2023-00012 0 0 090000648559b25e
FDA-2022-N-3184-0001 FDA FDA-2022-N-3184 Medical Devices; Physical Medicine Devices; Classification of the Virtual Reality Behavioral Therapy Device for Pain Relief Rule Final Rule 2023-01-06T05:00:00Z 2023 1 2023-01-06T05:00:00Z   2023-01-06T14:33:20Z 2023-00014 0 0 090000648559b338
FDA-2022-N-3224-0001 FDA FDA-2022-N-3224 Medical Devices; Neurological Devices; Classification of the Brain Stimulation Programming Planning Software Rule Final Rule 2023-01-05T05:00:00Z 2023 1 2023-01-05T05:00:00Z   2023-01-05T14:44:22Z 2022-28603 0 0 090000648558aa21
FDA-2019-F-3519-0002 FDA FDA-2019-F-3519 Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3 Rule Final Rule with Request for Comments 2023-01-05T05:00:00Z 2023 1 2023-01-05T05:00:00Z 2023-02-07T04:59:59Z 2023-02-07T02:00:23Z 2022-28428 0 0 090000648558a92f
FDA-2022-N-3239-0001 FDA FDA-2022-N-3239 Medical Devices; Orthopedic Devices; Classification of the Implantable Post- Surgical Kinematic Measurement Knee Device Rule Final Rule 2023-01-05T05:00:00Z 2023 1 2023-01-05T05:00:00Z   2023-01-05T14:47:58Z 2022-28604 0 0 090000648558a9d9
FDA-2022-N-3191-0001 FDA FDA-2022-N-3191 Medical Devices; Orthopedic Devices; Classification of the Bone Indentation Device Rule Final Rule 2023-01-05T05:00:00Z 2023 1 2023-01-05T05:00:00Z   2023-01-05T14:44:02Z 2022-28601 0 0 090000648558aa1e
FDA-2000-N-0011-0025 FDA Uniform Compliance Date for Food Labeling Regulations FDA-2000-N-0011 Uniform Compliance Date for Food Labeling Regulations Rule Final Rule 2023-01-03T05:00:00Z 2023 1 2023-01-03T05:00:00Z 2023-03-07T04:59:59Z 2023-03-07T02:01:12Z 2022-27902 0 0 090000648557e81d
FDA-2022-N-3207-0001 FDA FDA-2022-N-3207 Medical Devices; Gastroenterology-Urology Devices; Classification of the Gastrointestinal Lesion SoftwareDetection System Rule Direct Final Rule 2023-01-03T05:00:00Z 2023 1 2023-01-03T05:00:00Z   2023-01-04T15:40:56Z 2022-28494 0 0 090000648557e719

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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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