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withdrawn,object_id FDA-2009-N-0582-0130,FDA,FDA-2009-N-0582,"Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear,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,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,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,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