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Data / Federal rules / Food and Drug Administration

Food and Drug Administration: 315 rules and proposed rules since January 2024

235 final rules and 80 proposed rules since January 11, 2024, 15 of them marked significant. 8 are open for comment now. Common topics: medical devices, biologics, laboratories, drugs, administrative practice and procedure.

SpecStream is the live web data engine for teams and agents. It reads every rule and proposed rule in the Federal Register each morning, and this page is that reading. Name your industry once and new rules, comment deadlines and effective dates arrive in your sheet, CRM, Slack or agent as they are published.

Open for comment

Every document, newest first

DocumentTypePublished
Action Levels for Cadmium in Processed Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability
2026-21670
Proposed ruleOct 23
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability
2026-21669
Proposed ruleOct 23
Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate
2026-20979
Final ruleOct 14
Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods
2026-20848 · significant
Final ruleOct 13
Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Nucleic Acid From Non-Viral Microorganism(s) Causing Sexually Transmitted Infections Using Home-Collected Specimens
2026-20727
Final ruleOct 9
Medical Devices; Cardiovascular Devices; Classification of the Infant Pulse Rate and Oxygen Saturation Monitor for Over-the-Counter Use
2026-20726
Final ruleOct 9
Medical Devices; Immunology and Microbiology Devices; Classification of the Hematopoietic Cell Enrichment Kit
2026-20725
Final ruleOct 9
Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants; Draft Guidance for Industry; Availability
2026-20721
Proposed ruleOct 9
Medical Devices; Exemptions From Premarket Notification: Class II Devices; Certain Clinical Toxicology Test Systems
2026-20448
Final ruleOct 6
Medical Devices; Immunology and Microbiology Devices; Classification of the High Throughput DNA Sequencing for Hereditary Cancer Predisposition Assessment Test System
2026-20443
Final ruleOct 6
Medical Devices; Cardiovascular Devices; Classification of the Hyperoxia Monitoring Device Adjunct to Pulse Oximetry
2026-20441
Final ruleOct 6
Medical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound System for Non-Thermal, Mechanical Tissue Ablation
2026-20440
Final ruleOct 6
Medical Devices; Gastroenterology-Urology Devices; Classification of the Flushing and Storage Solution for Vascular Autografts at Room Temperature
2026-20075
Final ruleSep 30
Filing of Color Additive Petition From Doehler GmbH; Request To Amend the Color Additive Regulations To Provide for the Safe Use of Calcium Sulfate in Various Foods at Levels Consistent With Good Manufacturing Practice
2026-19658
Proposed ruleSep 25
Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D2 Inactive Bakers Yeast
2026-19656
Final ruleSep 25
Nonclinical Testing Terminology
2026-19350
Final ruleSep 22
Nonclinical Testing Terminology
2026-19349
Proposed ruleSep 22
Medical Devices; Exemption From Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer-Aided Triage and Notification Devices
2026-19074
Final ruleSep 17
Medical Devices; Cardiovascular Devices; Classification of the Cardiovascular Machine Learning-Based Notification Software
2026-18612
Final ruleSep 11
Green Innovation GmbH; Withdrawal of Food Additive Petition (Animal Use)
2026-18469
Proposed ruleSep 10
Medical Devices; Cardiovascular Devices; Classification of the Mechanical Deviation Device for Esophageal Protection During Cardiac Ablation Procedures
2026-18433
Final ruleSep 10
Medical Devices; Cardiovascular Devices; Classification of the Temperature Regulation Device for Esophageal Protection During Cardiac Ablation Procedures
2026-18432
Final ruleSep 10
Medical Devices; Cardiovascular Devices; Classification of the Extravascular Support for an Arteriovenous Fistula for Vascular Access
2026-18431
Final ruleSep 10
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Anti-Tumor Necrosis Factor Alpha Monoclonal Antibody Test System for Inflammatory Bowel Disease
2026-18430
Final ruleSep 10
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Cooperative Powered Surgical Assist Device for ENT Surgery
2026-18429
Final ruleSep 10
Medical Devices; Gastroenterology-Urology Devices; Classification of the Implanted Tibial Electrical Urinary Continence Device
2026-18428
Final ruleSep 10
Medical Devices; Radiology Devices; Classification of the Vaginal Hydrogel Packing System
2026-18427
Final ruleSep 10
Medical Devices; General Hospital and Personal Use Devices; Classification of the Whole Room Microbial Reduction Device
2026-18426
Final ruleSep 10
Gardenia Blue Interest Group; Filing of Color Additive Petition
2026-16944
Proposed ruleAug 19
International Association of Color Manufacturers; Filing of Color Additive Petition
2026-16943
Proposed ruleAug 19
Food Additives Permitted in Feed and Drinking Water of Animals; Chromium DL-methionine Chelate
2026-16942
Final ruleAug 19
GNT USA, LLC.; Filing of Color Additive Petition
2026-16939
Proposed ruleAug 19
Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments
2026-16729
Proposed ruleAug 17
Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer
2026-16728
Proposed ruleAug 17
Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product
2026-16727
Final ruleAug 17
Guide To Minimize Biological Hazards in Ready-to-Eat Fresh-Cut Produce; Guidance for Industry; Availability
2026-16420
Final ruleAug 12
Substances Generally Recognized as Safe
2026-16296 · significant
Proposed ruleAug 11
Radiology Devices; Reclassification of Digital Breast Tomosynthesis System
2026-16209
Proposed ruleAug 10
Medical Devices; Radiology Devices; Classification of the Fludeoxyglucose F18-Guided Radiation Therapy System
2026-15963
Final ruleAug 6
Micro-Tracers, Inc.; Response to Objections and Requests for a Public Hearing
2026-15920
Final ruleAug 5
Modification of Certain Terminology in Title 21; Reopening of the Comment Period
2026-15671
Proposed ruleAug 3
Medical Devices; Radiology Devices; Classification of the Phase-Changing Fiducial Marker for Radiation Therapy
2026-15303
Final ruleJul 29
Medical Devices; General Hospital and Personal Use Devices; Classification of the Active Noise Attenuation System for Infant Incubators
2026-15075
Final ruleJul 27
Medical Devices; Gastroenterology-Urology Devices; Classification of the Non-Medicated Topical Formulation for Treatment of Erectile Dysfunction
2026-15074
Final ruleJul 27
Evonik Corporation, Filing of Food Additive Petition (Animal Use)
2026-15021
Proposed ruleJul 24
Medical Devices; Orthopedic Devices; Classification of the Intraoperative Surgical Angle Measurement Tool
2026-14987
Final ruleJul 24
Medical Devices; General Hospital and Personal Use Devices; Classification of the Diabetes Digital Behavioral Therapeutic Device
2026-14986
Final ruleJul 24
Medical Devices; Immunology and Microbiology Devices; Classification of the Over-the-Counter Test To Detect SARS-CoV-2 From Clinical Specimens
2026-14985
Final ruleJul 24
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Prognostic Test for Assessment of Chronic Kidney Disease Progression
2026-14984
Final ruleJul 24
Revocation of the Color Additive Listing for Use of Orange B on Casings or Surfaces of Frankfurters and Sausages
2026-14910
Final ruleJul 23
Proposal To Revoke the Color Additive Listing for Use of Citrus Red No. 2 on the Skins of Mature Oranges
2026-14909
Proposed ruleJul 23
Food Standards of Identity Modernization; Pasteurized Orange Juice
2026-14573
Final ruleJul 20
Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
2026-14073 · significant
Proposed ruleJul 13
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor
2026-13716
Final ruleJul 7
Medical Devices; Anesthesiology Devices; Classification of the Monitor for Opioid Induced Impairment of Oxygenation
2026-13140
Final ruleJun 30
Medical Devices; General and Plastic Surgery Devices; Classification of the Skin Patch for Treatment of Hyperhidrosis
2026-13139
Final ruleJun 30
Medical Devices; Orthopedic Devices; Classification of the Medial Knee Implanted Shock Absorber
2026-13101
Final ruleJun 29
Establishment Registration and Product Listing for Tobacco Products
2026-13047 · significant
Proposed ruleJun 29
Medical Devices; General Hospital and Personal Use Devices; Classification of the Infant Supine Sleep System
2026-12905
Final ruleJun 26
Medical Devices; Neurological Devices; Classification of the External Lower Extremity Nerve Stimulator for Restless Legs Syndrome
2026-12904
Final ruleJun 26
Medical Devices; General and Plastic Surgery Devices; Classification of the Breast Implant Suction Retrieval System
2026-12903
Final ruleJun 26
Medical Devices; Immunology and Microbiology Devices; Classification of the SARS-CoV-2 Serology Test
2026-12902
Final ruleJun 26
Medical Devices; Neurological Devices; Classification of the Computerized Behavioral Therapy Device for the Treatment of Fibromyalgia Symptoms
2026-12901
Final ruleJun 26
Medical Devices; Clinical Chemistry and Toxicology Devices; Classification of the Prognostic Test for Development or Progression of Preeclampsia
2026-12900
Final ruleJun 26
Medical Devices; General Hospital and Personal Use Devices; Classification of the Foam or Gel Chemical Sterilant/High Level Disinfectant
2026-12899
Final ruleJun 26
Sterigenics U.S., LLC; Filing of Food Additive Petition
2026-12855
Proposed ruleJun 25
Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Traction Device
2026-12445
Final ruleJun 22
Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Light-Projecting Measuring Device
2026-12444
Final ruleJun 22
Medical Devices; Immunology and Microbiology Devices; Classification of the Simple In Vitro Diagnostic Device for the Detection of Secreted Proteins From Bacillus Species (spp.) in Human Clinical Samples
2026-12443
Final ruleJun 22
Medical Devices; Radiology Devices; Classification of the Radiological Machine Learning-Based Quantitative Imaging Software With Predetermined Change Control Plan
2026-12166
Final ruleJun 17
Medical Devices; Gastroenterology-Urology Devices; Classification of the Ingestible Gastrointestinal Blood Detection Capsule
2026-12165
Final ruleJun 17
Amendment and Revocation of Organizational Information Regulations
2026-11998
Final ruleJun 15
Medical Devices; Immunology and Microbiology Devices; Classification of the Spinal Muscular Atrophy Newborn Screening Test System
2026-11740
Final ruleJun 11
Medical Devices; Immunology and Microbiology Devices; Classification of the Simple Point-of-Care Device to Directly Detect SARS-CoV-2 Viral Targets From Clinical Specimens in Near-Patient Settings
2026-11739
Final ruleJun 11
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Combined Acoustic and Electrical External Stimulation Device for the Relief of Tinnitus
2026-11589
Final ruleJun 10
Medical Devices; Orthopedic Devices; Classification of the Resorbable Calcium Salt Bone Void Filler Containing a Single Approved Aminoglycoside Antibacterial
2026-11308
Final ruleJun 5
Medical Devices; Orthopedic Devices; Classification of the Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented or Uncemented Prosthesis
2026-11306
Final ruleJun 5
Medical Devices; Orthopedic Devices; Classification of the Absorbable Metallic Bone Fixation Fastener
2026-11302
Final ruleJun 5
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address; Correction
2026-11104
Final ruleJun 3
Medical Devices; General Hospital and Personal Use Devices; Classification of the Rigid Sterilization Container With Electronic Monitoring
2026-10908
Final ruleJun 1
Medical Devices; Anesthesiology Devices; Classification of the Real-Time Ultrasound Anatomy Visualization and Labeling Device for Ultrasound Guided Regional Anesthesia
2026-10907
Final ruleJun 1
Medical Devices; Anesthesiology Devices; Classification of the Adjunctive Pain Measurement Device for Anesthesiology
2026-10905
Final ruleJun 1
Medical Devices; Gastroenterology-Urology Devices; Classification of the Orally Ingested Transient Device for Constipation
2026-10904
Final ruleJun 1
Medical Devices; Dental Devices; Classification of the Intraoral Cooling Device
2026-10899
Final ruleJun 1
Medical Devices; Hematology and Pathology Devices; Classification of the Von Willebrand Factor Assay
2026-10898
Final ruleJun 1
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Oropharyngeal Electrical Stimulator
2026-10894
Final ruleJun 1
Medical Devices; Neurological Devices; Classification of the Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms
2026-10675
Final ruleMay 29
Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Suturing Device for Altering Gastric Anatomy for Weight Loss
2026-10621
Final ruleMay 28
Food Additive Petition From Environmental Defense Fund, et al.; Request To Amend the Food Additive Regulations To Remove the Solvents Benzene, Ethylene Dichloride, Methylene Chloride, and Trichloroethylene; Reopening of the Comment Period
2026-10615
Proposed ruleMay 28
Color Additive Petition from Environmental Defense Fund, et al.; Request To Amend the Color Additive Regulations To Remove the Solvents Ethylene Dichloride, Methylene Chloride, and Trichloroethylene; Reopening of the Comment Period
2026-10614
Proposed ruleMay 28
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microorganism Nucleic Acids and Resistance Markers From Patients With Suspected Orthopedic Infection
2026-09335
Final ruleMay 12
Medical Devices; Obstetrical and Gynecological Devices; Classification of the External Condom for Anal Intercourse or Vaginal Intercourse
2026-09152
Final ruleMay 8
Modification of Certain Terminology in Title 21
2026-08826
Proposed ruleMay 6
Medical Devices; Ophthalmic Devices; Classification of the Corneal Storage Medium With Preservatives Including Antifungals
2026-08813
Final ruleMay 6
Medical Devices; Immunology and Microbiology Devices; Classification of the Circulating Tumor Cell Enrichment Device
2026-08812
Final ruleMay 6
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Preserve and Stabilize Relative Abundances of Microbial Nucleic Acids in Clinical Samples
2026-08811
Final ruleMay 6
Medical Devices; General and Plastic Surgery Devices; Classification of the Phototherapy Device for Reducing the Appearance of Acute Post-Surgical Incisions
2026-08497
Final ruleMay 1
Medical Devices; Cardiovascular Devices; Classification of the Laser-Powered Inferior Vena Cava Filter Retrieval Catheter
2026-08426
Final ruleApr 30
Medical Devices; Neurological Devices; Classification of the Brain Temperature Measurement System
2026-08425
Final ruleApr 30
Medical Devices; Radiology Devices; Classification of the Radiation Therapy Marking Device
2026-08424
Final ruleApr 30
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Setmelanotide Eligibility Gene Variant Detection System
2026-07863
Final ruleApr 22
Medical Devices; Anesthesiology Devices; Classification of the Device for Sleep Apnea Testing Based on Mandibular Movement
2026-07862
Final ruleApr 22
Medical Devices; Ophthalmic Devices; Classification of the Digital Therapy Device for Amblyopia
2026-07861
Final ruleApr 22
Medical Devices; Immunology and Microbiology Devices; Classification of the Alzheimer's Disease Pathology Assessment Test
2026-07860
Final ruleApr 22
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor Address
2026-07500
Final ruleApr 16
Medical Devices; Orthopedic Devices; Classification of the Manual Surgical Instrument for Appropriate Patient Selection for Orthopedic Implant
2026-07367
Final ruleApr 16
Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators
2026-07366
Final ruleApr 16
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Transcutaneous Electrical Nerve Stimulator for the Relief of Congestion
2026-07365
Final ruleApr 16
Filing of Color Additive Petition From the International Association of Color Manufacturers; Request To Amend the Color Additive Regulations To Remove the Solvents Methylene Chloride, Trichloroethylene, and Ethylene Dichloride
2026-06295
Proposed ruleApr 1
Microbiology Devices; Reclassification of Mycobacterium Tuberculosis Cell-Mediated Immunity Tests and Immune Response Enzyme-Linked Immunospot Tests
2026-06064
Proposed ruleMar 30
General and Plastic Surgery Devices; Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed Software-Aided Adjunctive Diagnostic Devices for Use on Skin Lesions by Physicians Trained in the Diagnosis and Management of Skin Cancer
2026-05772
Final ruleMar 25
Listing of Color Additive Exempt From Certification; Spirulina Extract; Delay of Effective Date
2026-05733
Final ruleMar 24
Listing of Color Additive Exempt From Certification; Beetroot Red; Delay of Effective Date
2026-05732
Final ruleMar 24
Effective Date of Requirement for Premarket Approval Applications for Blood Irradiators Intended To Prevent Metastasis
2026-05322
Proposed ruleMar 18
Medical Devices; Radiology Devices; Classification of Blood Irradiators
2026-05320
Proposed ruleMar 18
General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products; Withdrawal of Proposed Rule
2026-05103
Proposed ruleMar 16
Revising the National Drug Code Format and Drug Label Barcode Requirements
2026-04368
Final ruleMar 5
Ecoflora Cares; Filing of Color Additive Petition
2026-04288
Proposed ruleMar 4
Kemin Industries, Inc.; Filing of Food Additive Petition (Animal Use)
2026-04284
Proposed ruleMar 4
Revocation of Regulations Regarding the Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and the European Community
2026-03286
Final ruleFeb 19
Revocation of Methods of Analysis Regulation
2026-03285
Final ruleFeb 19
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor Address
2026-02331
Final ruleFeb 6
Listing of Color Additives Exempt From Certification; Spirulina Extract
2026-02314
Final ruleFeb 6
Listing of Color Additives Exempt From Certification; Beetroot Red
2026-02313
Final ruleFeb 6
Medical Devices; Neurological Devices; Classification of the Electrical Tongue Nerve Stimulator To Treat Motor Deficits
2025-23413
Final ruleDec 19, 2025
Medical Devices; Quality Management System Regulation Technical Amendments
2025-21955
Final ruleDec 4, 2025
Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products; Withdrawal
2025-21407 · significant
Proposed ruleNov 28, 2025
Green Innovation GmbH; Filing of Food Additive Petition (Animal Use)
2025-21226
Proposed ruleNov 26, 2025
Medical Devices; Neurological Devices; Classification of Field Generator Positioning Device
2025-21218
Final ruleNov 26, 2025
Medical Devices; Gastroenterology-Urology Devices; Classification of the Anchored Esophageal Sheath
2025-21217
Final ruleNov 26, 2025
Immunology and Microbiology Devices; Reclassification of Nucleic Acid-Based Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product; Proposed Amendment; Proposed Order; Request for Comments
2025-21071
Proposed ruleNov 25, 2025
Listing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue; Confirmation of Effective Date
2025-19166
Final ruleOct 1, 2025
Revocation of Food Standards for 11 Products Not Currently Sold; Confirmation of Effective Date
2025-18730
Final ruleSep 26, 2025
Prior Notice: Adding Requirement To Submit Mail Tracking Number for Articles of Food Arriving by International Mail and Timeframe for Post-Refusal and Post-Hold Submissions
2025-18655
Final ruleSep 25, 2025
Regulation Identification Number 0910-AJ05 Medical Devices; Laboratory Developed Tests; Implementation of Vacatur
2025-18239
Final ruleSep 19, 2025
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address; Correction
2025-18217
Final ruleSep 19, 2025
Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices
2025-18082
Final ruleSep 18, 2025
Radiological Health Regulations; Technical Amendments
2025-18080
Final ruleSep 18, 2025
Proposal To Remove the Color Additive Listing for Use of Orange B on Casings or Surfaces of Frankfurters and Sausages
2025-18023
Proposed ruleSep 17, 2025
Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3 in Yogurt and Other Cultured Dairy Products Fermented With Lactobacillus delbrueckii, Subspecies bulgaricus, and Streptococcus thermophilus
2025-16946
Final ruleSep 4, 2025
Secondary Direct Food Additives Permitted in Food for Human Consumption; Hydrogen Peroxide
2025-16898
Final ruleSep 3, 2025
Biomin GmbH; Filing of Food Additive Petition (Animal Use)
2025-16859
Proposed ruleSep 3, 2025
Advisory Committee; Arthritis Advisory Committee; Termination; Removal From List of Standing Committees
2025-16629
Final ruleAug 29, 2025
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address
2025-16079
Final ruleAug 22, 2025
Listing of Color Additives Exempt From Certification; Calcium Phosphate; Confirmation of Effective Date
2025-16047
Final ruleAug 21, 2025
Listing of Color Additives Exempt From Certification; Galdieria Extract Blue; Confirmation of Effective Date
2025-16046
Final ruleAug 21, 2025
Listing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract; Confirmation of Effective Date
2025-16045
Final ruleAug 21, 2025
Medical Devices; Gastroenterology-Urology Devices; Classification of the Laparoscopic Gastrointestinal Sizing Tool
2025-16041
Final ruleAug 21, 2025
Medical Devices; Orthopedic Devices; Classification of Orthopedic Manual Surgical Instrumentation for Use With Non-Fusion Spinous Process Spacer Devices
2025-16040
Final ruleAug 21, 2025
Medical Devices; Orthopedic Devices; Classification of Orthopedic Manual Surgical Instrumentation for Use With Total Disc Replacement Devices
2025-16039
Final ruleAug 21, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Mutation Detection Test for Myeloproliferative Neoplasms
2025-16038
Final ruleAug 21, 2025
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Pharmacogenetic Assessment System
2025-16037
Final ruleAug 21, 2025
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Menopause Test System
2025-16036
Final ruleAug 21, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Cancer Predisposition Risk Assessment System
2025-16035
Final ruleAug 21, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of A Multiplex Respiratory Panel To Detect and Identify Emerging Respiratory Pathogen(s) and Common Respiratory Pathogens in Human Clinical Specimens
2025-16034
Final ruleAug 21, 2025
Medical Devices; Radiology Devices; Classification of the Liver Iron Concentration Imaging Companion Diagnostic for Deferasirox
2025-16033
Final ruleAug 21, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Postnatal Chromosomal Copy Number Variation Detection System
2025-16032
Final ruleAug 21, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Anti-Phospholipase A2 Receptor Immunological Test System
2025-16031
Final ruleAug 21, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Device That Detects Nucleic Acid Sequences From Microorganisms Associated With Vaginitis and Bacterial Vaginosis
2025-16030
Final ruleAug 21, 2025
Evonik Corporation; Filing of Food Additive Petition (Animal Use)
2025-15792
Proposed ruleAug 19, 2025
Food Standards of Identity Modernization; Pasteurized Orange Juice; Proposed Rule; Correction
2025-15473
Proposed ruleAug 14, 2025
Requirements for Additional Traceability Records for Certain Foods: Compliance Date Extension
2025-14967
Proposed ruleAug 7, 2025
Food Standards of Identity Modernization; Pasteurized Orange Juice
2025-14949
Proposed ruleAug 6, 2025
Listing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue; Correction
2025-14905
Final ruleAug 6, 2025
Spoonbill Foundation; Filing of Food Additive Petition
2025-14339
Proposed ruleJul 29, 2025
APIX Biosciences US LLC; Filing of Food Additive Petition (Animal Use)
2025-14335
Proposed ruleJul 29, 2025
Regulatory Hearing Before the Food and Drug Administration
2025-14203
Final ruleJul 28, 2025
Proposal To Revoke 18 Standards of Identity for Dairy Products
2025-13424
Proposed ruleJul 17, 2025
Revocation of Food Standards for 11 Products Not Currently Sold
2025-13423
Proposed ruleJul 17, 2025
Revocation of Food Standards for 11 Products Not Currently Sold
2025-13421
Final ruleJul 17, 2025
Proposal To Revoke 23 Standards of Identity for Foods
2025-13420
Proposed ruleJul 17, 2025
Listing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue
2025-13175
Final ruleJul 15, 2025
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Muscular Dystrophy Newborn Screening Test
2025-11796
Final ruleJun 26, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Herpes Simplex Virus Nucleic Acid-Based Assay for Central Nervous System Infections
2025-11794
Final ruleJun 26, 2025
Medical Devices; Hematology and Pathology Devices; Classification of the Fluorescence In Situ Hybridization-Based Detection of Chromosomal Abnormalities From Patients With Hematologic Malignancies
2025-11793
Final ruleJun 26, 2025
Medical Devices; Radiology Devices; Classification of the Cream for X-Ray Attenuation
2025-11791
Final ruleJun 26, 2025
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Lysosomal Storage Disorder Newborn Screening Test System
2025-11781
Final ruleJun 26, 2025
Medical Devices; Exemptions From Premarket Notification: Class II Devices; Clinical Electronic Thermometers
2025-11207
Final ruleJun 18, 2025
Medical Devices; Radiology Devices; Classification of the Radiological Computer-Assisted Detection and Diagnosis Software
2025-10789
Final ruleJun 13, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Clinical Mass Spectrometry Microorganism Identification and Differentiation System
2025-10788
Final ruleJun 13, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Cellular Analysis System for Multiplexed Antimicrobial Susceptibility Testing
2025-10787
Final ruleJun 13, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Fungal Nucleic Acids Directly in Respiratory Specimens
2025-10786
Final ruleJun 13, 2025
Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product
2025-10549
Proposed ruleJun 11, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect Bacterial Protease Activity in Chronic Wound Fluid
2025-09883
Final ruleJun 2, 2025
Medical Devices; Radiology Devices; Classification of the Radiological Acquisition and/or Optimization Guidance System
2025-09837
Final ruleJun 2, 2025
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Anti-Mullerian Hormone Test System
2025-09776
Final ruleMay 30, 2025
Listing of Color Additives; Myoglobin; Confirmation of Effective Date
2025-09680
Final ruleMay 29, 2025
Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event: Draft Guidance for Industry; Reopening of Comment Period
2025-09653
Proposed ruleMay 29, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Inherited Nucleotide Repeat Disorder Deoxyribonucleic Acid Test
2025-09641
Final ruleMay 29, 2025
Medical Devices; Gastroenterology-Urology Devices; Classification of the Temporarily-Placed Urethral Opening System for Symptoms of Benign Prostatic Hyperplasia
2025-09640
Final ruleMay 29, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Zika Virus Serological Reagents
2025-09639
Final ruleMay 29, 2025
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Plazomicin Test System
2025-09638
Final ruleMay 29, 2025
Food Additives Permitted in Feed and Drinking Water of Animals; Selenium
2025-08864
Final ruleMay 19, 2025
Listing of Color Additives Exempt From Certification; Galdieria Extract Blue
2025-08250
Final ruleMay 12, 2025
Listing of Color Additives Exempt From Certification; Calcium Phosphate
2025-08249
Final ruleMay 12, 2025
Listing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract
2025-08248
Final ruleMay 12, 2025
Food Labeling: Front-of-Package Nutrition Information; Extension of Comment Period
2025-08204 · significant
Proposed ruleMay 9, 2025
Medical Devices; Hematology and Pathology Devices; Classification of the Coagulation System for the Measurement of Whole Blood Viscoelastic Properties in Perioperative Patients
2025-08151
Final ruleMay 9, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microbial Nucleic Acids by Fluorescence In Situ Hybridization in Clinical Specimens
2025-08150
Final ruleMay 9, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect Nucleic Acids From Non-Viral Microorganism(s) Causing Sexually Transmitted Infections and Associated Resistance Marker(s)
2025-08149
Final ruleMay 9, 2025
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Voriconazole Test System
2025-08148
Final ruleMay 9, 2025
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Breast Milk Macronutrients Test System
2025-08147
Final ruleMay 9, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Cytomegalovirus Nucleic Acid Detection Device for Congenital Cytomegalovirus Infection
2025-08146
Final ruleMay 9, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Microbial Nucleic Acid Storage and Stabilization Device
2025-08145
Final ruleMay 9, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Measure Non-Microbial Analytes To Aid in the Detection and Identification of Localized Human Infections
2025-08144
Final ruleMay 9, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the DNA-Based Test To Measure Minimal Residual Disease in Hematological Malignancies
2025-08143
Final ruleMay 9, 2025
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor
2025-08137
Final ruleMay 9, 2025
Nonprescription Drug Product With an Additional Condition for Nonprescription Use
2025-04978 · significant
Final ruleMar 25, 2025
Impossible Foods, Inc.; Filing of Color Additive Petition
2025-04034
Proposed ruleMar 14, 2025
Food Labeling: Nutrient Content Claims; Definition of Term “Healthy”
2025-03118
Final ruleFeb 25, 2025
Nonprescription Drug Product With an Additional Condition for Nonprescription Use
2025-01840 · significant
Final ruleJan 27, 2025
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address
2025-01226
Final ruleJan 21, 2025
Listing of Color Additives Exempt From Certification; Myoglobin
2025-01239
Final ruleJan 17, 2025
Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments; Withdrawal
2025-01145
Final ruleJan 17, 2025
Color Additive Petition From Center for Science in the Public Interest, et al.; Request To Revoke Color Additive Listing for Use of FD&C Red No. 3 in Food and Ingested Drugs
2025-00830
Final ruleJan 16, 2025
Food Labeling: Front-of-Package Nutrition Information
2025-00778 · significant
Proposed ruleJan 16, 2025
Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products
2025-00397
Proposed ruleJan 16, 2025
Establishing Sanitation Programs for Low-Moisture Ready-To-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event; Draft Guidance for Industry; Availability
2024-31528
Proposed ruleJan 7, 2025
Considerations for Complying With 21 CFR 211.110; Draft Guidance for Industry; Availability
2024-31356
Final ruleJan 6, 2025
Uniform Compliance Date for Food Labeling Regulations
2024-31419
Final ruleDec 31, 2024
Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products
2024-30544 · significant
Proposed ruleDec 27, 2024
Food Labeling: Nutrient Content Claims; Definition of Term “Healthy”
2024-29957
Final ruleDec 27, 2024
Monterey Mushrooms, LLC; Filing of Food Additive Petition
2024-30362
Proposed ruleDec 26, 2024
Nonprescription Drug Product With an Additional Condition for Nonprescription Use
2024-30261 · significant
Final ruleDec 26, 2024
Leprino Nutrition; Filing of Food Additive Petition
2024-29248
Proposed ruleDec 12, 2024
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor
2024-28061
Final ruleDec 2, 2024
Color Additive Certification; Increase in Fees for Certification Services
2024-25974 · significant
Final ruleNov 8, 2024
Indirect Food Additives: Adhesives and Components of Coatings; Paper and Paperboard Components; Polymers; Adjuvants, Production Aids, and Sanitizers
2024-25122
Final ruleOct 30, 2024
Environmental Defense Fund, et al.; Response to Objections and Requests for a Public Hearing
2024-25120
Proposed ruleOct 30, 2024
New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address
2024-24820
Final ruleOct 28, 2024
Food and Drug Administration Enforcement Policy for Association of American Feed Control Officials-Defined Animal Feed Ingredients; Guidance for Industry; Availability
2024-24715
Final ruleOct 24, 2024
Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments; Correction
2024-24100
Final ruleOct 18, 2024
Medical Devices; Quality System Regulation Amendments; Correction
2024-23701
Final ruleOct 15, 2024
PHM Brands; Withdrawal of Food Additive Petition
2024-21934
Proposed ruleSep 26, 2024
Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices
2024-21932
Proposed ruleSep 25, 2024
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need To Know About the Food and Drug Administration Regulation; Small Entity Compliance Guide; Availability
2024-21840
Final ruleSep 24, 2024
DSM Biomedical; Filing of Color Additive Petition
2024-21684
Proposed ruleSep 23, 2024
Microbiology Devices; Reclassification of Cytomegalovirus Deoxyribonucleic Acid Quantitative Assay Devices Intended for Transplant Patient Management
2024-21616
Final ruleSep 23, 2024
Revocation of Regulations Regarding the Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community
2024-21559
Proposed ruleSep 20, 2024
Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments
2024-21232
Proposed ruleSep 20, 2024
Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments
2024-21231
Final ruleSep 20, 2024
Medical Devices; Immunology and Microbiology Devices; Classification of the Quantitative Viral Nucleic Acid Test for Transplant Patient Management
2024-21086
Final ruleSep 17, 2024
Medical Devices; Therapeutic Devices; Classification of the Pediatric Continuous Renal Replacement Therapy System
2024-20999
Final ruleSep 16, 2024
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect or Measure Nucleic Acid From Viruses Associated With Head and Neck Cancers
2024-20896
Final ruleSep 16, 2024
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Clozapine Test System
2024-20895
Final ruleSep 16, 2024
Enforcement Policy for Required Warnings for Cigarette Packages and Advertisements; Guidance for Industry; Availability
2024-20850
Final ruleSep 13, 2024
Medical Devices; Immunology and Microbiology Devices; Classification of the Whole Exome Sequencing Constituent Device
2024-20550
Final ruleSep 11, 2024
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Blood Collection Device for Cell-Free Nucleic Acids
2024-20254
Final ruleSep 9, 2024
Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Pancreatic Debridement Device
2024-20248
Final ruleSep 9, 2024
Medical Devices; Gastroenterology-Urology Devices; Classification of the Hemodialyzer With Expanded Solute Removal Profile
2024-20081
Final ruleSep 6, 2024
Medical Devices; Ophthalmic Devices; Classification of the Hydrophilic Re-Coating Solution
2024-19882
Final ruleSep 5, 2024
Medical Devices; Dental Devices; Classification of the Radiofrequency Toothbrush
2024-19868
Final ruleSep 5, 2024
Food Additives Permitted in Feed and Drinking Water of Animals; Pichia Pastoris Dried Yeast
2024-19856
Final ruleSep 5, 2024
Medical Devices; Hematology and Pathology Devices; Classification of the Heparin and Direct Oral Factor Xa Inhibitor Drug Test System
2024-19824
Final ruleSep 5, 2024
Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Open Loop Fluid Therapy Recommender
2024-19736
Final ruleSep 5, 2024
Medical Devices; Orthopedic Devices; Classification of the Intervertebral Body Graft Containment Device
2024-19726
Final ruleSep 3, 2024
Medical Devices; Dental Devices; Classification of the Neuromuscular Tongue Muscle Stimulator for the Reduction of Snoring and Obstructive Sleep Apnea
2024-19725
Final ruleSep 3, 2024
Medical Devices; Physical Medicine Devices; Classification of the External Compression Device for Internal Jugular Vein Compression
2024-19722
Final ruleSep 3, 2024
Medical Devices; Neurological Devices; Classification of the Digital Therapy Device for Attention Deficit Hyperactivity Disorder
2024-19720
Final ruleSep 3, 2024
Prohibition of Sale of Tobacco Products to Persons Younger Than 21 Years of Age
2024-19481 · significant
Final ruleAug 30, 2024
Medical Devices and Device-Led Combination Products; Voluntary Malfunction Summary Reporting for Manufacturers
2024-19414
Final ruleAug 29, 2024
Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide; Guidance for Industry and Food and Drug Administration Staff; Availability
2024-19059
Final ruleAug 26, 2024
Food Additives Permitted in Feed and Drinking Water of Animals; Fermented Ammoniated Condensed Whey
2024-18824
Final ruleAug 22, 2024
Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Certain Tobacco Products
2024-18343
Proposed ruleAug 16, 2024
Medical Devices; General Hospital and Personal Use Devices; Classification of the Intravenous Catheter Force-Activated Separation Device
2024-18267
Final ruleAug 16, 2024
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Nucleic Acid Targets Including SARS-CoV-2 in Respiratory Specimens
2024-18266
Final ruleAug 16, 2024
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Selected Microbial Agents That Cause Acute Febrile Illness
2024-18264
Final ruleAug 16, 2024
Food and Drug Administration Enforcement Policy for Association of American Feed Control Officials-Defined Animal Feed Ingredients; Draft Guidance for Industry; Availability
2024-17781
Proposed ruleAug 9, 2024
GNT USA, LLC; Filing of Color Additive Petition
2024-17090
Proposed ruleAug 5, 2024
Filing of Food Additive Petition From Environmental Defense Fund, Breast Cancer Prevention Partners, Center for Food Safety, Environmental Working Group, Tom Neltner, and Maricel Maffini; Request To Amend the Food Additive Regulations To Remove Authorization of Fluorinated Polyethylene; Reopening of the Comment Period; Correction
2024-16337
Proposed ruleJul 25, 2024
Phytolon Ltd.; Filing of Color Additive Petition
2024-15892
Proposed ruleJul 18, 2024
Blood Pressure and Pulse Donor Eligibility Requirements: Compliance Policy; Guidance for Industry; Availability
2024-15228
Final ruleJul 18, 2024
Advisory Committee; Allergenic Products Advisory Committee; Termination; Removal From List of Standing Committees
2024-15136
Final ruleJul 10, 2024
Revocation of Authorization for Use of Brominated Vegetable Oil in Food
2024-14300
Final ruleJul 3, 2024
Medicated Feed Mill License; Veterinary Feed Directive Drugs; Change of Address
2024-13678
Final ruleJun 21, 2024
Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases
2024-13190
Final ruleJun 18, 2024
Requirements for Additional Traceability Records for Certain Foods; Proposed Exemption for Cottage Cheese Regulated by the National Conference on Interstate Milk Shipments Grade “A” Pasteurized Milk Ordinance
2024-13236
Proposed ruleJun 17, 2024
Food Additives Permitted in Feed and Drinking Water of Animals; Ethyl Cellulose
2024-12533
Final ruleJun 7, 2024
Laboratory Accreditation for Analyses of Foods; Program Implementation; Determination of Sufficient Laboratory Capacity for Import-Related Food Testing Covered by the Regulation
2024-12027
Final ruleJun 3, 2024
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Appendix 1; Extension of Comment Period
2024-11987
Proposed ruleMay 31, 2024
Administrative Destruction
2024-11564
Final ruleMay 31, 2024
Advisory Committee; Science Advisory Board to the National Center for Toxicological Research; Termination; Removal From List of Standing Committees
2024-11811
Final ruleMay 30, 2024
Color Additive Certification; Increase in Fees for Certification Services; Extension of the Comment Period
2024-11639
Proposed ruleMay 28, 2024
Labeling Requirements for Approved or Conditionally Approved New Animal Drugs; Extension of Comment Period
2024-11229
Proposed ruleMay 22, 2024
Ophthalmic Devices; Reclassification of Ultrasound Cyclodestructive Device
2024-10895
Final ruleMay 20, 2024
Lonza Greenwood LLC; Filing of Color Additive Petition
2024-10888
Proposed ruleMay 17, 2024
Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
2024-10602
Final ruleMay 15, 2024
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications, Change of Sponsor, Change of Sponsor Address
2024-10586
Final ruleMay 15, 2024
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water
2024-09153 · significant
Final ruleMay 6, 2024
Medical Devices; Laboratory Developed Tests
2024-08935
Final ruleMay 6, 2024
Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration Under Section 564; Draft Guidance for Laboratory Manufacturers and Food and Drug Administration Staff; Availability
2024-08934
Proposed ruleMay 6, 2024
Food Additives Permitted in Feed and Drinking Water of Animals; Condensed, Extracted Glutamic Acid Fermentation Product
2024-09073
Final ruleApr 29, 2024
Revocation of Uses of Partially Hydrogenated Oils in Foods: Guidance for Industry; Small Entity Compliance Guide; Availability
2024-08955
Final ruleApr 29, 2024
Filing of Food Additive Petition From Environmental Defense Fund, Breast Cancer Prevention Partners, Center for Food Safety, Environmental Working Group, Tom Neltner, and Maricel Maffini; Request To Amend the Food Additive Regulations To Remove Authorization of Fluorinated Polyethylene
2024-09027
Proposed ruleApr 26, 2024
Color Additive Certification; Increase in Fees for Certification Services; Reopening of the Comment Period
2024-08950 · significant
Proposed ruleApr 26, 2024
Banned Devices; Proposal To Ban Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior
2024-06037
Proposed ruleMar 26, 2024
Food Additives: Food Contact Substance Notification That Is No Longer Effective
2024-05802
Final ruleMar 22, 2024
Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act
2024-05801
Proposed ruleMar 20, 2024
Medical Devices; Technical Amendments
2024-05473
Final ruleMar 15, 2024
Frozen Cherry Pie; Revocation of a Standard of Identity and a Standard of Quality
2024-04598
Final ruleMar 15, 2024
Filing of Color Additive Petition From Phytolon Ltd.
2024-05216
Proposed ruleMar 12, 2024
Labeling Requirements for Approved or Conditionally Approved New Animal Drugs
2024-04840
Proposed ruleMar 12, 2024
Advisory Committee; Genetic Metabolic Diseases Advisory Committee; Addition to List of Standing Committees
2024-04751
Final ruleMar 6, 2024
Key Information and Facilitating Understanding in Informed Consent; Draft Guidance for Sponsors, Investigators, and Institutional Review Boards; Availability
2024-04377
Proposed ruleMar 1, 2024
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications, Change of Sponsor, Change of Sponsor Address
2024-03765
Final ruleFeb 27, 2024
User Fees; Technical Amendment
2024-03777
Final ruleFeb 26, 2024
Advisory Committee; Digital Health Advisory Committee; Addition to List of Standing Committees
2024-03618
Final ruleFeb 22, 2024
Biologics License Applications and Master Files
2024-02741
Final ruleFeb 12, 2024
Sensient Colors, LLC.; Filing of Color Additive Petition
2024-02576
Final ruleFeb 8, 2024
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability
2024-01911
Proposed ruleFeb 2, 2024
Medical Devices; Quality System Regulation Amendments
2024-01709
Final ruleFeb 2, 2024
Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate
2024-01796
Final ruleJan 30, 2024
Listing of Color Additives Exempt From Certification; Jagua (Genipin-Glycine) Blue; Confirmation of Effective Date
2024-01106
Final ruleJan 23, 2024
Filing of Food Additive Petition From Environmental Defense Fund, et al.; Request To Amend the Food Additive Regulations To Remove the Solvents Benzene, Ethylene Dichloride, Methylene Chloride, and Trichloroethylene
2024-00411
Proposed ruleJan 11, 2024
Filing of Color Additive Petition From Environmental Defense Fund, et al.; Request To Amend the Color Additive Regulations To Remove the Solvents Ethylene Dichloride, Methylene Chloride, and Trichloroethylene
2024-00410
Proposed ruleJan 11, 2024

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