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withdrawn,object_id FDA-2018-D-1459-0047,FDA,FDA-2018-D-1459,"Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual- Column Labeling, and Miscellaneous Topics; Guidance for Industry; Availability",Rule,Notice of Interim Rule,2019-12-31T05:00:00Z,2019,12,2019-12-31T05:00:00Z,,2019-12-31T15:10:26Z,2019-27868,0,0,090000648425d410 FDA-2017-N-1129-0057,FDA,FDA-2017-N-1129,"Medical Devices; Exemptions From Premarket Notification for Class I and Class II Devices",Rule,Final Rule,2019-12-30T05:00:00Z,2019,12,2019-12-30T05:00:00Z,,2019-12-30T16:00:40Z,2019-27394,0,0,090000648425877b FDA-2017-N-1610-0002,FDA,FDA-2017-N-1610,"Medical Devices; Exemptions From Premarket Notification for Class I and Class II Devices",Rule,Final Rule,2019-12-30T05:00:00Z,2019,12,2019-12-30T05:00:00Z,,2019-12-30T16:04:58Z,2019-27394,0,0,0900006484256f8e FDA-2014-N-1209-0315,FDA,FDA-2014-N-1209,Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Devices Intended To Treat Anxiety and/ or Insomnia; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Devices Intended To Treat Depression,Rule,Final Rule,2019-12-20T05:00:00Z,2019,12,2019-12-20T05:00:00Z,,2019-12-20T13:47:06Z,2019-27295,0,0,0900006484240022 FDA-2018-C-4464-0019,FDA,FDA-2018-C-4464,Listing of Color Additives Exempt From Certification; Soy Leghemoglobin,Rule,Final Rule,2019-12-19T05:00:00Z,2019,12,2019-12-19T05:00:00Z,,2019-12-19T15:01:44Z,2019-27173,0,0,0900006484235cb1 FDA-2018-N-0628-0020,FDA,FDA-2018-N-0628,Medical Device Submissions: Amending Premarket Regulations That Require Multiple Copies and Specify Paper Copies To Be Required in Electronic Format,Rule,Final Rule,2019-12-16T05:00:00Z,2019,12,2019-12-16T05:00:00Z,,2019-12-16T16:22:23Z,2019-27047,0,0,090000648421276f FDA-2017-N-6924-0015,FDA,FDA-2017-N-6924,"Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation",Rule,Final Rule,2019-12-16T05:00:00Z,2019,12,2019-12-16T05:00:00Z,,2019-12-16T16:15:20Z,2019-27046,0,0,0900006484212728 FDA-2019-N-2484-0001,FDA,FDA-2019-N-2484,Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Continuous Glucose Monitor Data Management System,Rule,Final Rule,2019-10-29T04:00:00Z,2019,10,2019-10-29T04:00:00Z,,2019-10-30T14:25:27Z,2019-23471,0,0,0900006484103fca FDA-2011-F-0171-0421,FDA,FDA-2011-F-0171,Food Labeling: Calorie Labeling of Articles of Food Sold From Certain Vending Machines; Front of Package Type Size,Rule,Final Rule,2019-10-28T04:00:00Z,2019,10,2019-10-28T04:00:00Z,,2019-10-28T12:36:01Z,2019-23276,0,0,09000064840fee46 FDA-2019-N-4328-0001,FDA,FDA-2019-N-4328,"Medical Devices; Ear, Nose, and Throat Devices; Classification of the Self-Fitting Air-Conduction Hearing Aid",Rule,Final Rule,2019-10-28T04:00:00Z,2019,10,2019-10-28T04:00:00Z,,2019-10-28T13:29:13Z,2019-23464,0,0,09000064840ff050 FDA-2019-N-2675-0001,FDA,FDA-2019-N-2675,Medical Devices; Physical Medicine Therapeutic Devices; Classification of the Internal Therapeutic Massager,Rule,Final Rule,2019-10-25T04:00:00Z,2019,10,2019-10-25T04:00:00Z,,2019-10-25T13:37:03Z,2019-23304,0,0,09000064840f8d85 FDA-2019-N-2711-0001,FDA,FDA-2019-N-2711,Medical Devices; Orthopedic Devices; Classification of Orthopedic Surgical Instrumentation Designed for Osteochondral Implants With Press-Fit Fixation,Rule,Final Rule,2019-10-25T04:00:00Z,2019,10,2019-10-25T04:00:00Z,,2019-10-25T12:57:01Z,2019-23307,0,0,09000064840f8c14 FDA-2019-N-0002-0003,FDA,FDA-2019-N-0002,New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor's Name and Address,Rule,Final Rule,2019-10-07T04:00:00Z,2019,10,2019-10-07T04:00:00Z,,2019-10-07T13:53:21Z,2019-21514,0,0,0900006484048afc FDA-2019-N-0002-0002,FDA,FDA-2019-N-0002,New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of Sponsors’ Names and Addresses,Rule,Final Rule,2019-08-09T04:00:00Z,2019,8,2019-08-09T04:00:00Z,,2019-08-09T12:45:08Z,2019-16884,0,0,0900006483e1d816 FDA-2019-N-0002-0001,FDA,FDA-2019-N-0002,"New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications",Rule,Withdrawal,2019-08-09T04:00:00Z,2019,8,2019-08-09T04:00:00Z,,2019-08-09T12:41:49Z,2019-16885,0,0,0900006483e1d71a FDA-2018-C-4464-0002,FDA,FDA-2018-C-4464,Listing of Color Additives Exempt From Certification; Soy Leghemoglobin,Rule,Final Rule,2019-08-01T04:00:00Z,2019,8,2019-08-01T04:00:00Z,2019-09-04T03:59:59Z,2019-09-05T01:06:25Z,2019-16374,0,0,0900006483dddc38 FDA-2011-N-0921-19183,FDA,FDA-2011-N-0921,Ext 002 standards-produce-extension-compliance-dates-subparte-FRIA-document re Extension of Compliance Dates,Rule,Final Rule,2019-07-24T04:00:00Z,2019,7,2019-07-24T04:00:00Z,,2019-07-24T13:46:00Z,,0,0,0900006483db0cd3 FDA-2011-N-0921-19181,FDA,FDA-2011-N-0921,Ext 000 List of references,Rule,Final Rule,2019-07-24T04:00:00Z,2019,7,2019-07-24T04:00:00Z,,2019-07-24T13:43:41Z,,0,0,0900006483db0cd1 FDA-2011-N-0921-19182,FDA,FDA-2011-N-0921,Ext 001 Produce Final RIA-10-28-2015 CLEAN_508ED re Extension of Compliance Dates,Rule,Final Rule,2019-07-24T04:00:00Z,2019,7,2019-07-24T04:00:00Z,,2019-07-24T13:45:26Z,,0,0,0900006483db0cd2 FDA-2012-N-1067-0018,FDA,FDA-2012-N-1067,New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food,Rule,Final Rule,2019-07-11T04:00:00Z,2019,7,2019-07-11T04:00:00Z,,2019-07-11T14:44:25Z,2019-14098,0,0,0900006483d7d205 FDA-2016-N-2378-0004,FDA,FDA-2016-N-2378,"Internal Agency Review of Decisions; Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and Radiological Health",Rule,Final Rule,2019-07-02T04:00:00Z,2019,7,2019-07-02T04:00:00Z,,2019-07-02T19:10:21Z,2019-14096,0,0,0900006483d55e8e FDA-2018-D-0671-0005,FDA,FDA-2018-D-0671,"Determining the Number of Employees for Purposes of the ""Small Business"" Definition (Current Good Manufacturing Practices and Preventive Controls Regulations for Human and Animal Food): Guidance for Industry; Availability",Rule,Notice of Interim Rule,2019-06-21T04:00:00Z,2019,6,2019-06-21T04:00:00Z,,2019-06-27T15:14:22Z,2019-13223,0,0,0900006483d2f681 FDA-2019-D-2011-0001,FDA,FDA-2019-D-2011,Guidance: Section 503A Bulks List Final Rule Questions and Answers; Small Entity Compliance Guide; Availability,Rule,Final Rule,2019-05-24T04:00:00Z,2019,5,2019-05-24T04:00:00Z,,2019-05-24T16:35:25Z,2019-10953,0,0,0900006483cc3e2e FDA-2018-N-3066-0010,FDA,FDA-2018-N-3066,"Medical Devices; Classification of Accessories Distinct From Other Devices; Finalized List of Accessories Suitable for Class I; Correction",Rule,Correction,2019-05-20T04:00:00Z,2019,5,2019-05-20T04:00:00Z,,2019-05-20T14:29:46Z,2019-10399,0,0,0900006483ca0d2c FDA-2008-N-0424-0034,FDA,FDA-2008-N-0424,Compliance Policy for Combination Product Postmarketing Safety Reporting; Immediately in Effect Guidance for Industry; Availability,Rule,Correction,2019-04-24T04:00:00Z,2019,4,2019-04-24T04:00:00Z,,2019-07-23T11:14:49Z,2019-08284,0,0,0900006483be9a6e FDA-2017-C-6238-0006,FDA,FDA-2017-C-6238,Listing of Color Additives Exempt From Certification; Synthetic Iron Oxide; Confirmation of Effective Date,Rule,Confirmation of Effective Date,2019-04-18T04:00:00Z,2019,4,2019-04-18T04:00:00Z,,2023-01-24T16:58:06Z,2019-07829,0,0,0900006483bb992d FDA-2019-N-0647-0001,FDA,FDA-2019-N-0647,Medical Devices; Anesthesiology Devices; Classification of the Ventilatory Electrical Impedance Tomograph,Rule,Final Rule,2019-04-15T04:00:00Z,2019,4,2019-04-15T04:00:00Z,,2019-04-15T13:38:27Z,2019-07463,0,0,0900006483ba2974 FDA-2016-N-0124-0281,FDA,FDA-2016-N-0124,Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use,Rule,Final Rule,2019-04-12T04:00:00Z,2019,4,2019-04-12T04:00:00Z,,2019-04-12T13:14:40Z,2019-06791,0,0,0900006483b89f68 FDA-2018-N-3066-0009,FDA,FDA-2018-N-3066,"Medical Devices; Classification of Accessories Distinct From Other Devices; Finalized List of Accessories Suitable for Class I",Rule,Direct Final Rule,2019-04-12T04:00:00Z,2019,4,2019-04-12T04:00:00Z,,2019-04-12T13:13:55Z,2019-07290,0,0,0900006483b89fcc FDA-2018-N-0002-0006,FDA,FDA-2018-N-0002,New Animal Drugs: Approval of New Animal Drug Applications; Changes of Sponsorship,Rule,Final Rule,2019-04-02T04:00:00Z,2019,4,2019-04-02T04:00:00Z,,2019-04-02T13:09:20Z,2019-06136,0,0,0900006483b571a1 FDA-2017-N-7007-0009,FDA,FDA-2017-N-7007,Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products,Rule,Final Rule,2019-04-02T04:00:00Z,2019,4,2019-04-02T04:00:00Z,,2019-04-02T13:50:48Z,2019-06187,0,0,0900006483b57290 FDA-2011-N-0920-2067,FDA,FDA-2011-N-0920,Implementing the Food and Drug Administration Food Safety Modernization Act; Technical Amendment,Rule,Final Rule,2019-04-02T04:00:00Z,2019,4,2019-04-02T04:00:00Z,,2019-04-02T12:58:59Z,2019-06141,0,0,0900006483b5797c FDA-2011-N-0922-0566,FDA,FDA-2011-N-0922,Implementing the Food and Drug Administration Food Safety Modernization Act; Technical Amendment,Rule,Final Rule,2019-04-02T04:00:00Z,2019,4,2019-04-02T04:00:00Z,,2019-04-02T12:58:03Z,2019-06141,0,0,0900006483b5714d FDA-2011-N-0921-19180,FDA,FDA-2011-N-0921,Implementing the Food and Drug Administration Food Safety Modernization Act; Technical Amendment,Rule,Final Rule,2019-04-02T04:00:00Z,2019,4,2019-04-02T04:00:00Z,,2019-04-02T12:59:31Z,2019-06141,0,0,0900006483b57980 FDA-2017-C-1951-0234,FDA,FDA-2017-C-1951,Reinstatement of Color Additive Listing for Lead Acetate,Rule,Final Rule,2019-04-01T04:00:00Z,2019,4,2019-04-01T04:00:00Z,,2019-04-01T16:25:55Z,2019-06238,0,0,0900006483b5129d FDA-2015-N-3785-0009,FDA,FDA-2015-N-3785,"Medical Devices; Orthopedic Devices; Classification of Posterior Cervical Screw Systems",Rule,Final Rule,2019-04-01T04:00:00Z,2019,4,2019-04-01T04:00:00Z,,2019-04-01T16:22:28Z,2019-06024,0,0,0900006483b511b1 FDA-2011-N-0103-0021,FDA,FDA-2011-N-0103,Microbiology Devices; Classification of In Vitro Diagnostic Devices for Bacillus Species Detection,Rule,Final Rule,2019-04-01T04:00:00Z,2019,4,2019-04-01T04:00:00Z,,2019-04-01T15:56:15Z,2019-06026,0,0,0900006483b512a0 FDA-2019-N-1345-0001,FDA,FDA-2019-N-1345,Medical Devices; Technical Amendment,Rule,Final Rule,2019-04-01T04:00:00Z,2019,4,2019-04-01T04:00:00Z,,2019-04-01T16:27:11Z,2019-06139,0,0,0900006483b513f0 FDA-2019-D-1266-0001,FDA,FDA-2019-D-1266,"Produce Safety Rule: Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds; Guidance for Industry; Availability",Rule,Policy Statement,2019-03-28T04:00:00Z,2019,3,2019-03-28T04:00:00Z,,2019-04-02T16:50:15Z,2019-05953,0,0,0900006483b37f47 FDA-2011-N-0921-19179,FDA,FDA-2011-N-0921,"Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Compliance Dates for Subpart E",Rule,Final Rule,2019-03-18T04:00:00Z,2019,3,2019-03-18T04:00:00Z,,2019-03-18T14:05:36Z,2019-04652,0,0,0900006483af67e1 FDA-2019-N-0360-0001,FDA,FDA-2019-N-0360,"Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microorganisms and Associated Resistance Marker Nucleic Acids Directly in Respiratory Specimens",Rule,Final Rule,2019-03-14T04:00:00Z,2019,3,2019-03-14T04:00:00Z,,2019-03-14T15:02:48Z,2019-04719,0,0,0900006483adea69 FDA-2019-N-0396-0001,FDA,FDA-2019-N-0396,Medical Devices; Neurological Devices; Classification of the Transcranial Magnetic Stimulation System for Neurological and Psychiatric Disorders and Conditions,Rule,Final Rule,2019-03-14T04:00:00Z,2019,3,2019-03-14T04:00:00Z,,2019-03-14T14:42:39Z,2019-04709,0,0,0900006483ade91a FDA-2018-N-0002-0004,FDA,FDA-2018-N-0002,"New Animal Drugs; Withdrawal of Approval of New Animal Drug Application",Rule,Withdrawal,2019-03-13T04:00:00Z,2019,3,2019-03-13T04:00:00Z,,2019-03-13T13:19:26Z,2019-04222,0,0,0900006483adaeb9 FDA-2018-N-0002-0005,FDA,FDA-2018-N-0002,New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship,Rule,Final Rule,2019-03-13T04:00:00Z,2019,3,2019-03-13T04:00:00Z,,2019-03-13T13:22:43Z,2019-04226,0,0,0900006483adaeba FDA-2015-F-2712-0003,FDA,FDA-2015-F-2712,"Food Additives Permitted in Feed and Drinking Water of Animals; Selenomethionine Hyd",Rule,Final Rule,2019-03-06T05:00:00Z,2019,3,2019-03-06T05:00:00Z,2019-04-06T03:59:59Z,2019-03-14T01:03:57Z,2019-03909,0,0,0900006483ac2419 FDA-2019-N-0138-0001,FDA,FDA-2019-N-0138,"Medical Devices; Obstetrical and Gynecological Devices; Classification of the Software Application for Contraception",Rule,Final Rule,2019-03-06T05:00:00Z,2019,3,2019-03-06T05:00:00Z,,2019-03-06T14:18:52Z,2019-04028,0,0,0900006483ac24f8 FDA-2019-N-0646-0001,FDA,FDA-2019-N-0646,Change of Address; Technical Amendment,Rule,Final Rule,2019-02-28T05:00:00Z,2019,2,2019-02-28T05:00:00Z,,2019-02-28T14:50:46Z,2019-03542,0,0,0900006483aaf4fd FDA-2017-F-4511-0002,FDA,FDA-2017-F-4511,"Food Additives Permitted in Feed and Drinking Water of Animals; Gamma- Linolenic Acid Safflower Oil",Rule,Final Rule,2019-02-28T05:00:00Z,2019,2,2019-02-28T05:00:00Z,2019-04-02T03:59:59Z,2019-04-02T01:02:23Z,2019-03514,0,0,0900006483aaf556 FDA-2019-N-0142-0001,FDA,FDA-2019-N-0142,Medical Devices; Dental Devices; Classification of the Auto Titration Device for Oral Appliances,Rule,Final Rule,2019-02-20T05:00:00Z,2019,2,2019-02-20T05:00:00Z,,2019-02-20T16:30:49Z,2019-02824,0,0,0900006483a8fd76 FDA-2016-N-3464-0029,FDA,FDA-2016-N-3464,"List of Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act",Rule,Final Rule,2019-02-19T05:00:00Z,2019,2,2019-02-19T05:00:00Z,,2019-02-19T14:46:18Z,2019-02367,0,0,0900006483a88bb0 FDA-1976-N-0476-0324,FDA,FDA-1976-N-0476,"Nonclinical Laboratory Studies, Good Laboratory Practice Regulations; Correction",Rule,Correction,2019-01-30T05:00:00Z,2019,1,2019-01-30T05:00:00Z,,2019-01-30T15:15:55Z,79-9094,0,0,0900006480521a45