Action Levels for Cadmium in Processed Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability 2026-21670 | Proposed rule | Oct 23 |
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability 2026-21669 | Proposed rule | Oct 23 |
Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate 2026-20979 | Final rule | Oct 14 |
Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods 2026-20848 · significant | Final rule | Oct 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 rule | Oct 9 |
Medical Devices; Cardiovascular Devices; Classification of the Infant Pulse Rate and Oxygen Saturation Monitor for Over-the-Counter Use 2026-20726 | Final rule | Oct 9 |
Medical Devices; Immunology and Microbiology Devices; Classification of the Hematopoietic Cell Enrichment Kit 2026-20725 | Final rule | Oct 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Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants; Draft Guidance for Industry; Availability 2026-20721 | Proposed rule | Oct 9 |
Medical Devices; Exemptions From Premarket Notification: Class II Devices; Certain Clinical Toxicology Test Systems 2026-20448 | Final rule | Oct 6 |
Medical Devices; Immunology and Microbiology Devices; Classification of the High Throughput DNA Sequencing for Hereditary Cancer Predisposition Assessment Test System 2026-20443 | Final rule | Oct 6 |
Medical Devices; Cardiovascular Devices; Classification of the Hyperoxia Monitoring Device Adjunct to Pulse Oximetry 2026-20441 | Final rule | Oct 6 |
Medical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound System for Non-Thermal, Mechanical Tissue Ablation 2026-20440 | Final rule | Oct 6 |
Medical Devices; Gastroenterology-Urology Devices; Classification of the Flushing and Storage Solution for Vascular Autografts at Room Temperature 2026-20075 | Final rule | Sep 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 rule | Sep 25 |
Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D2 Inactive Bakers Yeast 2026-19656 | Final rule | Sep 25 |
Nonclinical Testing Terminology 2026-19350 | Final rule | Sep 22 |
Nonclinical Testing Terminology 2026-19349 | Proposed rule | Sep 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 rule | Sep 17 |
Medical Devices; Cardiovascular Devices; Classification of the Cardiovascular Machine Learning-Based Notification Software 2026-18612 | Final rule | Sep 11 |
Green Innovation GmbH; Withdrawal of Food Additive Petition (Animal Use) 2026-18469 | Proposed rule | Sep 10 |
Medical Devices; Cardiovascular Devices; Classification of the Mechanical Deviation Device for Esophageal Protection During Cardiac Ablation Procedures 2026-18433 | Final rule | Sep 10 |
Medical Devices; Cardiovascular Devices; Classification of the Temperature Regulation Device for Esophageal Protection During Cardiac Ablation Procedures 2026-18432 | Final rule | Sep 10 |
Medical Devices; Cardiovascular Devices; Classification of the Extravascular Support for an Arteriovenous Fistula for Vascular Access 2026-18431 | Final rule | Sep 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 rule | Sep 10 |
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Cooperative Powered Surgical Assist Device for ENT Surgery 2026-18429 | Final rule | Sep 10 |
Medical Devices; Gastroenterology-Urology Devices; Classification of the Implanted Tibial Electrical Urinary Continence Device 2026-18428 | Final rule | Sep 10 |
Medical Devices; Radiology Devices; Classification of the Vaginal Hydrogel Packing System 2026-18427 | Final rule | Sep 10 |
Medical Devices; General Hospital and Personal Use Devices; Classification of the Whole Room Microbial Reduction Device 2026-18426 | Final rule | Sep 10 |
Gardenia Blue Interest Group; Filing of Color Additive Petition 2026-16944 | Proposed rule | Aug 19 |
International Association of Color Manufacturers; Filing of Color Additive Petition 2026-16943 | Proposed rule | Aug 19 |
Food Additives Permitted in Feed and Drinking Water of Animals; Chromium DL-methionine Chelate 2026-16942 | Final rule | Aug 19 |
GNT USA, LLC.; Filing of Color Additive Petition 2026-16939 | Proposed rule | Aug 19 |
Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments 2026-16729 | Proposed rule | Aug 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 rule | Aug 17 |
Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product 2026-16727 | Final rule | Aug 17 |
Guide To Minimize Biological Hazards in Ready-to-Eat Fresh-Cut Produce; Guidance for Industry; Availability 2026-16420 | Final rule | Aug 12 |
Substances Generally Recognized as Safe 2026-16296 · significant | Proposed rule | Aug 11 |
Radiology Devices; Reclassification of Digital Breast Tomosynthesis System 2026-16209 | Proposed rule | Aug 10 |
Medical Devices; Radiology Devices; Classification of the Fludeoxyglucose F18-Guided Radiation Therapy System 2026-15963 | Final rule | Aug 6 |
Micro-Tracers, Inc.; Response to Objections and Requests for a Public Hearing 2026-15920 | Final rule | Aug 5 |
Modification of Certain Terminology in Title 21; Reopening of the Comment Period 2026-15671 | Proposed rule | Aug 3 |
Medical Devices; Radiology Devices; Classification of the Phase-Changing Fiducial Marker for Radiation Therapy 2026-15303 | Final rule | Jul 29 |
Medical Devices; General Hospital and Personal Use Devices; Classification of the Active Noise Attenuation System for Infant Incubators 2026-15075 | Final rule | Jul 27 |
Medical Devices; Gastroenterology-Urology Devices; Classification of the Non-Medicated Topical Formulation for Treatment of Erectile Dysfunction 2026-15074 | Final rule | Jul 27 |
Evonik Corporation, Filing of Food Additive Petition (Animal Use) 2026-15021 | Proposed rule | Jul 24 |
Medical Devices; Orthopedic Devices; Classification of the Intraoperative Surgical Angle Measurement Tool 2026-14987 | Final rule | Jul 24 |
Medical Devices; General Hospital and Personal Use Devices; Classification of the Diabetes Digital Behavioral Therapeutic Device 2026-14986 | Final rule | Jul 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 rule | Jul 24 |
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Prognostic Test for Assessment of Chronic Kidney Disease Progression 2026-14984 | Final rule | Jul 24 |
Revocation of the Color Additive Listing for Use of Orange B on Casings or Surfaces of Frankfurters and Sausages 2026-14910 | Final rule | Jul 23 |
Proposal To Revoke the Color Additive Listing for Use of Citrus Red No. 2 on the Skins of Mature Oranges 2026-14909 | Proposed rule | Jul 23 |
Food Standards of Identity Modernization; Pasteurized Orange Juice 2026-14573 | Final rule | Jul 20 |
Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments 2026-14073 · significant | Proposed rule | Jul 13 |
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor 2026-13716 | Final rule | Jul 7 |
Medical Devices; Anesthesiology Devices; Classification of the Monitor for Opioid Induced Impairment of Oxygenation 2026-13140 | Final rule | Jun 30 |
Medical Devices; General and Plastic Surgery Devices; Classification of the Skin Patch for Treatment of Hyperhidrosis 2026-13139 | Final rule | Jun 30 |
Medical Devices; Orthopedic Devices; Classification of the Medial Knee Implanted Shock Absorber 2026-13101 | Final rule | Jun 29 |
Establishment Registration and Product Listing for Tobacco Products 2026-13047 · significant | Proposed rule | Jun 29 |
Medical Devices; General Hospital and Personal Use Devices; Classification of the Infant Supine Sleep System 2026-12905 | Final rule | Jun 26 |
Medical Devices; Neurological Devices; Classification of the External Lower Extremity Nerve Stimulator for Restless Legs Syndrome 2026-12904 | Final rule | Jun 26 |
Medical Devices; General and Plastic Surgery Devices; Classification of the Breast Implant Suction Retrieval System 2026-12903 | Final rule | Jun 26 |
Medical Devices; Immunology and Microbiology Devices; Classification of the SARS-CoV-2 Serology Test 2026-12902 | Final rule | Jun 26 |
Medical Devices; Neurological Devices; Classification of the Computerized Behavioral Therapy Device for the Treatment of Fibromyalgia Symptoms 2026-12901 | Final rule | Jun 26 |
Medical Devices; Clinical Chemistry and Toxicology Devices; Classification of the Prognostic Test for Development or Progression of Preeclampsia 2026-12900 | Final rule | Jun 26 |
Medical Devices; General Hospital and Personal Use Devices; Classification of the Foam or Gel Chemical Sterilant/High Level Disinfectant 2026-12899 | Final rule | Jun 26 |
Sterigenics U.S., LLC; Filing of Food Additive Petition 2026-12855 | Proposed rule | Jun 25 |
Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Traction Device 2026-12445 | Final rule | Jun 22 |
Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Light-Projecting Measuring Device 2026-12444 | Final rule | Jun 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 rule | Jun 22 |
Medical Devices; Radiology Devices; Classification of the Radiological Machine Learning-Based Quantitative Imaging Software With Predetermined Change Control Plan 2026-12166 | Final rule | Jun 17 |
Medical Devices; Gastroenterology-Urology Devices; Classification of the Ingestible Gastrointestinal Blood Detection Capsule 2026-12165 | Final rule | Jun 17 |
Amendment and Revocation of Organizational Information Regulations 2026-11998 | Final rule | Jun 15 |
Medical Devices; Immunology and Microbiology Devices; Classification of the Spinal Muscular Atrophy Newborn Screening Test System 2026-11740 | Final rule | Jun 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 rule | Jun 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 rule | Jun 10 |
Medical Devices; Orthopedic Devices; Classification of the Resorbable Calcium Salt Bone Void Filler Containing a Single Approved Aminoglycoside Antibacterial 2026-11308 | Final rule | Jun 5 |
Medical Devices; Orthopedic Devices; Classification of the Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented or Uncemented Prosthesis 2026-11306 | Final rule | Jun 5 |
Medical Devices; Orthopedic Devices; Classification of the Absorbable Metallic Bone Fixation Fastener 2026-11302 | Final rule | Jun 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 rule | Jun 3 |
Medical Devices; General Hospital and Personal Use Devices; Classification of the Rigid Sterilization Container With Electronic Monitoring 2026-10908 | Final rule | Jun 1 |
Medical Devices; Anesthesiology Devices; Classification of the Real-Time Ultrasound Anatomy Visualization and Labeling Device for Ultrasound Guided Regional Anesthesia 2026-10907 | Final rule | Jun 1 |
Medical Devices; Anesthesiology Devices; Classification of the Adjunctive Pain Measurement Device for Anesthesiology 2026-10905 | Final rule | Jun 1 |
Medical Devices; Gastroenterology-Urology Devices; Classification of the Orally Ingested Transient Device for Constipation 2026-10904 | Final rule | Jun 1 |
Medical Devices; Dental Devices; Classification of the Intraoral Cooling Device 2026-10899 | Final rule | Jun 1 |
Medical Devices; Hematology and Pathology Devices; Classification of the Von Willebrand Factor Assay 2026-10898 | Final rule | Jun 1 |
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Oropharyngeal Electrical Stimulator 2026-10894 | Final rule | Jun 1 |
Medical Devices; Neurological Devices; Classification of the Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms 2026-10675 | Final rule | May 29 |
Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Suturing Device for Altering Gastric Anatomy for Weight Loss 2026-10621 | Final rule | May 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 rule | May 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 rule | May 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 rule | May 12 |
Medical Devices; Obstetrical and Gynecological Devices; Classification of the External Condom for Anal Intercourse or Vaginal Intercourse 2026-09152 | Final rule | May 8 |
Modification of Certain Terminology in Title 21 2026-08826 | Proposed rule | May 6 |
Medical Devices; Ophthalmic Devices; Classification of the Corneal Storage Medium With Preservatives Including Antifungals 2026-08813 | Final rule | May 6 |
Medical Devices; Immunology and Microbiology Devices; Classification of the Circulating Tumor Cell Enrichment Device 2026-08812 | Final rule | May 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 rule | May 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 rule | May 1 |
Medical Devices; Cardiovascular Devices; Classification of the Laser-Powered Inferior Vena Cava Filter Retrieval Catheter 2026-08426 | Final rule | Apr 30 |
Medical Devices; Neurological Devices; Classification of the Brain Temperature Measurement System 2026-08425 | Final rule | Apr 30 |
Medical Devices; Radiology Devices; Classification of the Radiation Therapy Marking Device 2026-08424 | Final rule | Apr 30 |
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Setmelanotide Eligibility Gene Variant Detection System 2026-07863 | Final rule | Apr 22 |
Medical Devices; Anesthesiology Devices; Classification of the Device for Sleep Apnea Testing Based on Mandibular Movement 2026-07862 | Final rule | Apr 22 |
Medical Devices; Ophthalmic Devices; Classification of the Digital Therapy Device for Amblyopia 2026-07861 | Final rule | Apr 22 |
Medical Devices; Immunology and Microbiology Devices; Classification of the Alzheimer's Disease Pathology Assessment Test 2026-07860 | Final rule | Apr 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 rule | Apr 16 |
Medical Devices; Orthopedic Devices; Classification of the Manual Surgical Instrument for Appropriate Patient Selection for Orthopedic Implant 2026-07367 | Final rule | Apr 16 |
Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators 2026-07366 | Final rule | Apr 16 |
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Transcutaneous Electrical Nerve Stimulator for the Relief of Congestion 2026-07365 | Final rule | Apr 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 rule | Apr 1 |
Microbiology Devices; Reclassification of Mycobacterium Tuberculosis Cell-Mediated Immunity Tests and Immune Response Enzyme-Linked Immunospot Tests 2026-06064 | Proposed rule | Mar 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 rule | Mar 25 |
Listing of Color Additive Exempt From Certification; Spirulina Extract; Delay of Effective Date 2026-05733 | Final rule | Mar 24 |
Listing of Color Additive Exempt From Certification; Beetroot Red; Delay of Effective Date 2026-05732 | Final rule | Mar 24 |
Effective Date of Requirement for Premarket Approval Applications for Blood Irradiators Intended To Prevent Metastasis 2026-05322 | Proposed rule | Mar 18 |
Medical Devices; Radiology Devices; Classification of Blood Irradiators 2026-05320 | Proposed rule | Mar 18 |
General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products; Withdrawal of Proposed Rule 2026-05103 | Proposed rule | Mar 16 |
Revising the National Drug Code Format and Drug Label Barcode Requirements 2026-04368 | Final rule | Mar 5 |
Ecoflora Cares; Filing of Color Additive Petition 2026-04288 | Proposed rule | Mar 4 |
Kemin Industries, Inc.; Filing of Food Additive Petition (Animal Use) 2026-04284 | Proposed rule | Mar 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 rule | Feb 19 |
Revocation of Methods of Analysis Regulation 2026-03285 | Final rule | Feb 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 rule | Feb 6 |
Listing of Color Additives Exempt From Certification; Spirulina Extract 2026-02314 | Final rule | Feb 6 |
Listing of Color Additives Exempt From Certification; Beetroot Red 2026-02313 | Final rule | Feb 6 |
Medical Devices; Neurological Devices; Classification of the Electrical Tongue Nerve Stimulator To Treat Motor Deficits 2025-23413 | Final rule | Dec 19, 2025 |
Medical Devices; Quality Management System Regulation Technical Amendments 2025-21955 | Final rule | Dec 4, 2025 |
Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products; Withdrawal 2025-21407 · significant | Proposed rule | Nov 28, 2025 |
Green Innovation GmbH; Filing of Food Additive Petition (Animal Use) 2025-21226 | Proposed rule | Nov 26, 2025 |
Medical Devices; Neurological Devices; Classification of Field Generator Positioning Device 2025-21218 | Final rule | Nov 26, 2025 |
Medical Devices; Gastroenterology-Urology Devices; Classification of the Anchored Esophageal Sheath 2025-21217 | Final rule | Nov 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 rule | Nov 25, 2025 |
Listing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue; Confirmation of Effective Date 2025-19166 | Final rule | Oct 1, 2025 |
Revocation of Food Standards for 11 Products Not Currently Sold; Confirmation of Effective Date 2025-18730 | Final rule | Sep 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 rule | Sep 25, 2025 |
Regulation Identification Number 0910-AJ05 Medical Devices; Laboratory Developed Tests; Implementation of Vacatur 2025-18239 | Final rule | Sep 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 rule | Sep 19, 2025 |
Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices 2025-18082 | Final rule | Sep 18, 2025 |
Radiological Health Regulations; Technical Amendments 2025-18080 | Final rule | Sep 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 rule | Sep 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 rule | Sep 4, 2025 |
Secondary Direct Food Additives Permitted in Food for Human Consumption; Hydrogen Peroxide 2025-16898 | Final rule | Sep 3, 2025 |
Biomin GmbH; Filing of Food Additive Petition (Animal Use) 2025-16859 | Proposed rule | Sep 3, 2025 |
Advisory Committee; Arthritis Advisory Committee; Termination; Removal From List of Standing Committees 2025-16629 | Final rule | Aug 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 rule | Aug 22, 2025 |
Listing of Color Additives Exempt From Certification; Calcium Phosphate; Confirmation of Effective Date 2025-16047 | Final rule | Aug 21, 2025 |
Listing of Color Additives Exempt From Certification; Galdieria Extract Blue; Confirmation of Effective Date 2025-16046 | Final rule | Aug 21, 2025 |
Listing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract; Confirmation of Effective Date 2025-16045 | Final rule | Aug 21, 2025 |
Medical Devices; Gastroenterology-Urology Devices; Classification of the Laparoscopic Gastrointestinal Sizing Tool 2025-16041 | Final rule | Aug 21, 2025 |
Medical Devices; Orthopedic Devices; Classification of Orthopedic Manual Surgical Instrumentation for Use With Non-Fusion Spinous Process Spacer Devices 2025-16040 | Final rule | Aug 21, 2025 |
Medical Devices; Orthopedic Devices; Classification of Orthopedic Manual Surgical Instrumentation for Use With Total Disc Replacement Devices 2025-16039 | Final rule | Aug 21, 2025 |
Medical Devices; Immunology and Microbiology Devices; Classification of the Mutation Detection Test for Myeloproliferative Neoplasms 2025-16038 | Final rule | Aug 21, 2025 |
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Pharmacogenetic Assessment System 2025-16037 | Final rule | Aug 21, 2025 |
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Menopause Test System 2025-16036 | Final rule | Aug 21, 2025 |
Medical Devices; Immunology and Microbiology Devices; Classification of the Cancer Predisposition Risk Assessment System 2025-16035 | Final rule | Aug 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 rule | Aug 21, 2025 |
Medical Devices; Radiology Devices; Classification of the Liver Iron Concentration Imaging Companion Diagnostic for Deferasirox 2025-16033 | Final rule | Aug 21, 2025 |
Medical Devices; Immunology and Microbiology Devices; Classification of the Postnatal Chromosomal Copy Number Variation Detection System 2025-16032 | Final rule | Aug 21, 2025 |
Medical Devices; Immunology and Microbiology Devices; Classification of the Anti-Phospholipase A2 Receptor Immunological Test System 2025-16031 | Final rule | Aug 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 rule | Aug 21, 2025 |
Evonik Corporation; Filing of Food Additive Petition (Animal Use) 2025-15792 | Proposed rule | Aug 19, 2025 |
Food Standards of Identity Modernization; Pasteurized Orange Juice; Proposed Rule; Correction 2025-15473 | Proposed rule | Aug 14, 2025 |
Requirements for Additional Traceability Records for Certain Foods: Compliance Date Extension 2025-14967 | Proposed rule | Aug 7, 2025 |
Food Standards of Identity Modernization; Pasteurized Orange Juice 2025-14949 | Proposed rule | Aug 6, 2025 |
Listing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue; Correction 2025-14905 | Final rule | Aug 6, 2025 |
Spoonbill Foundation; Filing of Food Additive Petition 2025-14339 | Proposed rule | Jul 29, 2025 |
APIX Biosciences US LLC; Filing of Food Additive Petition (Animal Use) 2025-14335 | Proposed rule | Jul 29, 2025 |
Regulatory Hearing Before the Food and Drug Administration 2025-14203 | Final rule | Jul 28, 2025 |
Proposal To Revoke 18 Standards of Identity for Dairy Products 2025-13424 | Proposed rule | Jul 17, 2025 |
Revocation of Food Standards for 11 Products Not Currently Sold 2025-13423 | Proposed rule | Jul 17, 2025 |
Revocation of Food Standards for 11 Products Not Currently Sold 2025-13421 | Final rule | Jul 17, 2025 |
Proposal To Revoke 23 Standards of Identity for Foods 2025-13420 | Proposed rule | Jul 17, 2025 |
Listing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue 2025-13175 | Final rule | Jul 15, 2025 |
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Muscular Dystrophy Newborn Screening Test 2025-11796 | Final rule | Jun 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 rule | Jun 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 rule | Jun 26, 2025 |
Medical Devices; Radiology Devices; Classification of the Cream for X-Ray Attenuation 2025-11791 | Final rule | Jun 26, 2025 |
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Lysosomal Storage Disorder Newborn Screening Test System 2025-11781 | Final rule | Jun 26, 2025 |
Medical Devices; Exemptions From Premarket Notification: Class II Devices; Clinical Electronic Thermometers 2025-11207 | Final rule | Jun 18, 2025 |
Medical Devices; Radiology Devices; Classification of the Radiological Computer-Assisted Detection and Diagnosis Software 2025-10789 | Final rule | Jun 13, 2025 |
Medical Devices; Immunology and Microbiology Devices; Classification of the Clinical Mass Spectrometry Microorganism Identification and Differentiation System 2025-10788 | Final rule | Jun 13, 2025 |
Medical Devices; Immunology and Microbiology Devices; Classification of the Cellular Analysis System for Multiplexed Antimicrobial Susceptibility Testing 2025-10787 | Final rule | Jun 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 rule | Jun 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 rule | Jun 11, 2025 |
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect Bacterial Protease Activity in Chronic Wound Fluid 2025-09883 | Final rule | Jun 2, 2025 |
Medical Devices; Radiology Devices; Classification of the Radiological Acquisition and/or Optimization Guidance System 2025-09837 | Final rule | Jun 2, 2025 |
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Anti-Mullerian Hormone Test System 2025-09776 | Final rule | May 30, 2025 |
Listing of Color Additives; Myoglobin; Confirmation of Effective Date 2025-09680 | Final rule | May 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 rule | May 29, 2025 |
Medical Devices; Immunology and Microbiology Devices; Classification of the Inherited Nucleotide Repeat Disorder Deoxyribonucleic Acid Test 2025-09641 | Final rule | May 29, 2025 |
Medical Devices; Gastroenterology-Urology Devices; Classification of the Temporarily-Placed Urethral Opening System for Symptoms of Benign Prostatic Hyperplasia 2025-09640 | Final rule | May 29, 2025 |
Medical Devices; Immunology and Microbiology Devices; Classification of the Zika Virus Serological Reagents 2025-09639 | Final rule | May 29, 2025 |
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Plazomicin Test System 2025-09638 | Final rule | May 29, 2025 |
Food Additives Permitted in Feed and Drinking Water of Animals; Selenium 2025-08864 | Final rule | May 19, 2025 |
Listing of Color Additives Exempt From Certification; Galdieria Extract Blue 2025-08250 | Final rule | May 12, 2025 |
Listing of Color Additives Exempt From Certification; Calcium Phosphate 2025-08249 | Final rule | May 12, 2025 |
Listing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract 2025-08248 | Final rule | May 12, 2025 |
Food Labeling: Front-of-Package Nutrition Information; Extension of Comment Period 2025-08204 · significant | Proposed rule | May 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 rule | May 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 rule | May 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 rule | May 9, 2025 |
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Voriconazole Test System 2025-08148 | Final rule | May 9, 2025 |
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Breast Milk Macronutrients Test System 2025-08147 | Final rule | May 9, 2025 |
Medical Devices; Immunology and Microbiology Devices; Classification of the Cytomegalovirus Nucleic Acid Detection Device for Congenital Cytomegalovirus Infection 2025-08146 | Final rule | May 9, 2025 |
Medical Devices; Immunology and Microbiology Devices; Classification of the Microbial Nucleic Acid Storage and Stabilization Device 2025-08145 | Final rule | May 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 rule | May 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 rule | May 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 rule | May 9, 2025 |
Nonprescription Drug Product With an Additional Condition for Nonprescription Use 2025-04978 · significant | Final rule | Mar 25, 2025 |
Impossible Foods, Inc.; Filing of Color Additive Petition 2025-04034 | Proposed rule | Mar 14, 2025 |
Food Labeling: Nutrient Content Claims; Definition of Term “Healthy” 2025-03118 | Final rule | Feb 25, 2025 |
Nonprescription Drug Product With an Additional Condition for Nonprescription Use 2025-01840 · significant | Final rule | Jan 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 rule | Jan 21, 2025 |
Listing of Color Additives Exempt From Certification; Myoglobin 2025-01239 | Final rule | Jan 17, 2025 |
Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments; Withdrawal 2025-01145 | Final rule | Jan 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 rule | Jan 16, 2025 |
Food Labeling: Front-of-Package Nutrition Information 2025-00778 · significant | Proposed rule | Jan 16, 2025 |
Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products 2025-00397 | Proposed rule | Jan 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 rule | Jan 7, 2025 |
Considerations for Complying With 21 CFR 211.110; Draft Guidance for Industry; Availability 2024-31356 | Final rule | Jan 6, 2025 |
Uniform Compliance Date for Food Labeling Regulations 2024-31419 | Final rule | Dec 31, 2024 |
Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products 2024-30544 · significant | Proposed rule | Dec 27, 2024 |
Food Labeling: Nutrient Content Claims; Definition of Term “Healthy” 2024-29957 | Final rule | Dec 27, 2024 |
Monterey Mushrooms, LLC; Filing of Food Additive Petition 2024-30362 | Proposed rule | Dec 26, 2024 |
Nonprescription Drug Product With an Additional Condition for Nonprescription Use 2024-30261 · significant | Final rule | Dec 26, 2024 |
Leprino Nutrition; Filing of Food Additive Petition 2024-29248 | Proposed rule | Dec 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 rule | Dec 2, 2024 |
Color Additive Certification; Increase in Fees for Certification Services 2024-25974 · significant | Final rule | Nov 8, 2024 |
Indirect Food Additives: Adhesives and Components of Coatings; Paper and Paperboard Components; Polymers; Adjuvants, Production Aids, and Sanitizers 2024-25122 | Final rule | Oct 30, 2024 |
Environmental Defense Fund, et al.; Response to Objections and Requests for a Public Hearing 2024-25120 | Proposed rule | Oct 30, 2024 |
New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address 2024-24820 | Final rule | Oct 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 rule | Oct 24, 2024 |
Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments; Correction 2024-24100 | Final rule | Oct 18, 2024 |
Medical Devices; Quality System Regulation Amendments; Correction 2024-23701 | Final rule | Oct 15, 2024 |
PHM Brands; Withdrawal of Food Additive Petition 2024-21934 | Proposed rule | Sep 26, 2024 |
Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices 2024-21932 | Proposed rule | Sep 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 rule | Sep 24, 2024 |
DSM Biomedical; Filing of Color Additive Petition 2024-21684 | Proposed rule | Sep 23, 2024 |
Microbiology Devices; Reclassification of Cytomegalovirus Deoxyribonucleic Acid Quantitative Assay Devices Intended for Transplant Patient Management 2024-21616 | Final rule | Sep 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 rule | Sep 20, 2024 |
Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments 2024-21232 | Proposed rule | Sep 20, 2024 |
Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments 2024-21231 | Final rule | Sep 20, 2024 |
Medical Devices; Immunology and Microbiology Devices; Classification of the Quantitative Viral Nucleic Acid Test for Transplant Patient Management 2024-21086 | Final rule | Sep 17, 2024 |
Medical Devices; Therapeutic Devices; Classification of the Pediatric Continuous Renal Replacement Therapy System 2024-20999 | Final rule | Sep 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 rule | Sep 16, 2024 |
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Clozapine Test System 2024-20895 | Final rule | Sep 16, 2024 |
Enforcement Policy for Required Warnings for Cigarette Packages and Advertisements; Guidance for Industry; Availability 2024-20850 | Final rule | Sep 13, 2024 |
Medical Devices; Immunology and Microbiology Devices; Classification of the Whole Exome Sequencing Constituent Device 2024-20550 | Final rule | Sep 11, 2024 |
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Blood Collection Device for Cell-Free Nucleic Acids 2024-20254 | Final rule | Sep 9, 2024 |
Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Pancreatic Debridement Device 2024-20248 | Final rule | Sep 9, 2024 |
Medical Devices; Gastroenterology-Urology Devices; Classification of the Hemodialyzer With Expanded Solute Removal Profile 2024-20081 | Final rule | Sep 6, 2024 |
Medical Devices; Ophthalmic Devices; Classification of the Hydrophilic Re-Coating Solution 2024-19882 | Final rule | Sep 5, 2024 |
Medical Devices; Dental Devices; Classification of the Radiofrequency Toothbrush 2024-19868 | Final rule | Sep 5, 2024 |
Food Additives Permitted in Feed and Drinking Water of Animals; Pichia Pastoris Dried Yeast 2024-19856 | Final rule | Sep 5, 2024 |
Medical Devices; Hematology and Pathology Devices; Classification of the Heparin and Direct Oral Factor Xa Inhibitor Drug Test System 2024-19824 | Final rule | Sep 5, 2024 |
Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Open Loop Fluid Therapy Recommender 2024-19736 | Final rule | Sep 5, 2024 |
Medical Devices; Orthopedic Devices; Classification of the Intervertebral Body Graft Containment Device 2024-19726 | Final rule | Sep 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 rule | Sep 3, 2024 |
Medical Devices; Physical Medicine Devices; Classification of the External Compression Device for Internal Jugular Vein Compression 2024-19722 | Final rule | Sep 3, 2024 |
Medical Devices; Neurological Devices; Classification of the Digital Therapy Device for Attention Deficit Hyperactivity Disorder 2024-19720 | Final rule | Sep 3, 2024 |
Prohibition of Sale of Tobacco Products to Persons Younger Than 21 Years of Age 2024-19481 · significant | Final rule | Aug 30, 2024 |
Medical Devices and Device-Led Combination Products; Voluntary Malfunction Summary Reporting for Manufacturers 2024-19414 | Final rule | Aug 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 rule | Aug 26, 2024 |
Food Additives Permitted in Feed and Drinking Water of Animals; Fermented Ammoniated Condensed Whey 2024-18824 | Final rule | Aug 22, 2024 |
Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Certain Tobacco Products 2024-18343 | Proposed rule | Aug 16, 2024 |
Medical Devices; General Hospital and Personal Use Devices; Classification of the Intravenous Catheter Force-Activated Separation Device 2024-18267 | Final rule | Aug 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 rule | Aug 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 rule | Aug 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 rule | Aug 9, 2024 |
GNT USA, LLC; Filing of Color Additive Petition 2024-17090 | Proposed rule | Aug 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 rule | Jul 25, 2024 |
Phytolon Ltd.; Filing of Color Additive Petition 2024-15892 | Proposed rule | Jul 18, 2024 |
Blood Pressure and Pulse Donor Eligibility Requirements: Compliance Policy; Guidance for Industry; Availability 2024-15228 | Final rule | Jul 18, 2024 |
Advisory Committee; Allergenic Products Advisory Committee; Termination; Removal From List of Standing Committees 2024-15136 | Final rule | Jul 10, 2024 |
Revocation of Authorization for Use of Brominated Vegetable Oil in Food 2024-14300 | Final rule | Jul 3, 2024 |
Medicated Feed Mill License; Veterinary Feed Directive Drugs; Change of Address 2024-13678 | Final rule | Jun 21, 2024 |
Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases 2024-13190 | Final rule | Jun 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 rule | Jun 17, 2024 |
Food Additives Permitted in Feed and Drinking Water of Animals; Ethyl Cellulose 2024-12533 | Final rule | Jun 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 rule | Jun 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 rule | May 31, 2024 |
Administrative Destruction 2024-11564 | Final rule | May 31, 2024 |
Advisory Committee; Science Advisory Board to the National Center for Toxicological Research; Termination; Removal From List of Standing Committees 2024-11811 | Final rule | May 30, 2024 |
Color Additive Certification; Increase in Fees for Certification Services; Extension of the Comment Period 2024-11639 | Proposed rule | May 28, 2024 |
Labeling Requirements for Approved or Conditionally Approved New Animal Drugs; Extension of Comment Period 2024-11229 | Proposed rule | May 22, 2024 |
Ophthalmic Devices; Reclassification of Ultrasound Cyclodestructive Device 2024-10895 | Final rule | May 20, 2024 |
Lonza Greenwood LLC; Filing of Color Additive Petition 2024-10888 | Proposed rule | May 17, 2024 |
Index of Legally Marketed Unapproved New Animal Drugs for Minor Species 2024-10602 | Final rule | May 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 rule | May 15, 2024 |
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water 2024-09153 · significant | Final rule | May 6, 2024 |
Medical Devices; Laboratory Developed Tests 2024-08935 | Final rule | May 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 rule | May 6, 2024 |
Food Additives Permitted in Feed and Drinking Water of Animals; Condensed, Extracted Glutamic Acid Fermentation Product 2024-09073 | Final rule | Apr 29, 2024 |
Revocation of Uses of Partially Hydrogenated Oils in Foods: Guidance for Industry; Small Entity Compliance Guide; Availability 2024-08955 | Final rule | Apr 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 rule | Apr 26, 2024 |
Color Additive Certification; Increase in Fees for Certification Services; Reopening of the Comment Period 2024-08950 · significant | Proposed rule | Apr 26, 2024 |
Banned Devices; Proposal To Ban Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior 2024-06037 | Proposed rule | Mar 26, 2024 |
Food Additives: Food Contact Substance Notification That Is No Longer Effective 2024-05802 | Final rule | Mar 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 rule | Mar 20, 2024 |
Medical Devices; Technical Amendments 2024-05473 | Final rule | Mar 15, 2024 |
Frozen Cherry Pie; Revocation of a Standard of Identity and a Standard of Quality 2024-04598 | Final rule | Mar 15, 2024 |
Filing of Color Additive Petition From Phytolon Ltd. 2024-05216 | Proposed rule | Mar 12, 2024 |
Labeling Requirements for Approved or Conditionally Approved New Animal Drugs 2024-04840 | Proposed rule | Mar 12, 2024 |
Advisory Committee; Genetic Metabolic Diseases Advisory Committee; Addition to List of Standing Committees 2024-04751 | Final rule | Mar 6, 2024 |
Key Information and Facilitating Understanding in Informed Consent; Draft Guidance for Sponsors, Investigators, and Institutional Review Boards; Availability 2024-04377 | Proposed rule | Mar 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 rule | Feb 27, 2024 |
User Fees; Technical Amendment 2024-03777 | Final rule | Feb 26, 2024 |
Advisory Committee; Digital Health Advisory Committee; Addition to List of Standing Committees 2024-03618 | Final rule | Feb 22, 2024 |
Biologics License Applications and Master Files 2024-02741 | Final rule | Feb 12, 2024 |
Sensient Colors, LLC.; Filing of Color Additive Petition 2024-02576 | Final rule | Feb 8, 2024 |
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability 2024-01911 | Proposed rule | Feb 2, 2024 |
Medical Devices; Quality System Regulation Amendments 2024-01709 | Final rule | Feb 2, 2024 |
Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate 2024-01796 | Final rule | Jan 30, 2024 |
Listing of Color Additives Exempt From Certification; Jagua (Genipin-Glycine) Blue; Confirmation of Effective Date 2024-01106 | Final rule | Jan 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 rule | Jan 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 rule | Jan 11, 2024 |