Food and Drug Administration: federal rules
The Food and Drug Administration published 96 final rules in 2026 so far and 68 in 2025, counted by the Tribune from the Federal Register.
Built by the Tribune's code from the Federal Register. No AI wrote this page. Updated Nov. 2, 2026.
Final rules 164
- Oct. 30, 2026
- Oct. 30, 2026
- Oct. 30, 2026
- Oct. 30, 2026
- Oct. 14, 2026Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate
Final rule · Food and Drug Administration · 21 CFR part 573
- Oct. 13, 2026Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods
Final rule · Food and Drug Administration · 21 CFR parts 130, 131, 133 and 13 more
- Oct. 9, 2026
- Oct. 9, 2026
- Oct. 9, 2026
- Oct. 6, 2026
- Oct. 6, 2026
- Oct. 6, 2026
- Oct. 6, 2026Medical Devices; Exemptions From Premarket Notification: Class II Devices; Certain Clinical Toxicology Test Systems
Final rule · Food and Drug Administration · 21 CFR part 862 · Opens the Federal Register
- Sept. 30, 2026Medical Devices; Gastroenterology-Urology Devices; Classification of the Flushing and Storage Solution for Vascular Autografts at Room Temperature
Final rule · Food and Drug Administration · 21 CFR part 876 · Opens the Federal Register
- Sept. 25, 2026Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D2 Inactive Bakers Yeast
Final rule · Food and Drug Administration · 21 CFR part 172 · Opens the Federal Register
- Sept. 22, 2026Nonclinical Testing Terminology
Final rule · Food and Drug Administration · 21 CFR parts 312, 314, 315 and 2 more · Opens the Federal Register
- Sept. 17, 2026Medical Devices; Exemption From Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer-Aided Triage and Notification Devices
Final rule · Food and Drug Administration · 21 CFR part 892 · Opens the Federal Register
- Sept. 11, 2026Medical Devices; Cardiovascular Devices; Classification of the Cardiovascular Machine Learning-Based Notification Software
Final rule · Food and Drug Administration · 21 CFR part 870 · Opens the Federal Register
- Sept. 10, 2026Medical Devices; General Hospital and Personal Use Devices; Classification of the Whole Room Microbial Reduction Device
Final rule · Food and Drug Administration · 21 CFR part 880 · Opens the Federal Register
- Sept. 10, 2026Medical Devices; Radiology Devices; Classification of the Vaginal Hydrogel Packing System
Final rule · Food and Drug Administration · 21 CFR part 892 · Opens the Federal Register
- Sept. 10, 2026Medical Devices; Gastroenterology-Urology Devices; Classification of the Implanted Tibial Electrical Urinary Continence Device
Final rule · Food and Drug Administration · 21 CFR part 876 · Opens the Federal Register
- Sept. 10, 2026Medical Devices; Ear, Nose, and Throat Devices; Classification of the Cooperative Powered Surgical Assist Device for ENT Surgery
Final rule · Food and Drug Administration · 21 CFR part 874 · Opens the Federal Register
- Sept. 10, 2026Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Anti-Tumor Necrosis Factor Alpha Monoclonal Antibody Test System for Inflammatory Bowel Disease
Final rule · Food and Drug Administration · 21 CFR part 862 · Opens the Federal Register
- Sept. 10, 2026Medical Devices; Cardiovascular Devices; Classification of the Extravascular Support for an Arteriovenous Fistula for Vascular Access
Final rule · Food and Drug Administration · 21 CFR part 870 · Opens the Federal Register
- Sept. 10, 2026Medical Devices; Cardiovascular Devices; Classification of the Temperature Regulation Device for Esophageal Protection During Cardiac Ablation Procedures
Final rule · Food and Drug Administration · 21 CFR part 870 · Opens the Federal Register
- Sept. 10, 2026Medical Devices; Cardiovascular Devices; Classification of the Mechanical Deviation Device for Esophageal Protection During Cardiac Ablation Procedures
Final rule · Food and Drug Administration · 21 CFR part 870 · Opens the Federal Register
- Aug. 19, 2026Food Additives Permitted in Feed and Drinking Water of Animals; Chromium DL-methionine Chelate
Final rule · Food and Drug Administration · 21 CFR part 573 · Opens the Federal Register
- Aug. 17, 2026Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product
Final rule · Food and Drug Administration · 21 CFR part 864 · Opens the Federal Register
- Aug. 12, 2026Guide To Minimize Biological Hazards in Ready-to-Eat Fresh-Cut Produce; Guidance for Industry; Availability
Final rule · Food and Drug Administration · 21 CFR part 117 · Opens the Federal Register
- Aug. 6, 2026Medical Devices; Radiology Devices; Classification of the Fludeoxyglucose F18-Guided Radiation Therapy System
Final rule · Food and Drug Administration · 21 CFR part 892 · Opens the Federal Register
- Aug. 5, 2026Micro-Tracers, Inc.; Response to Objections and Requests for a Public Hearing
Final rule · Food and Drug Administration · 21 CFR part 74 · Opens the Federal Register
- July 29, 2026Medical Devices; Radiology Devices; Classification of the Phase-Changing Fiducial Marker for Radiation Therapy
Final rule · Food and Drug Administration · 21 CFR part 892 · Opens the Federal Register
- July 27, 2026Medical Devices; Gastroenterology-Urology Devices; Classification of the Non-Medicated Topical Formulation for Treatment of Erectile Dysfunction
Final rule · Food and Drug Administration · 21 CFR part 876 · Opens the Federal Register
- July 27, 2026Medical Devices; General Hospital and Personal Use Devices; Classification of the Active Noise Attenuation System for Infant Incubators
Final rule · Food and Drug Administration · 21 CFR part 880 · Opens the Federal Register
- July 24, 2026Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Prognostic Test for Assessment of Chronic Kidney Disease Progression
Final rule · Food and Drug Administration · 21 CFR part 862 · Opens the Federal Register
- July 24, 2026Medical Devices; Immunology and Microbiology Devices; Classification of the Over-the-Counter Test To Detect SARS-CoV-2 From Clinical Specimens
Final rule · Food and Drug Administration · 21 CFR part 866 · Opens the Federal Register
- July 24, 2026Medical Devices; General Hospital and Personal Use Devices; Classification of the Diabetes Digital Behavioral Therapeutic Device
Final rule · Food and Drug Administration · 21 CFR part 880 · Opens the Federal Register
- July 24, 2026Medical Devices; Orthopedic Devices; Classification of the Intraoperative Surgical Angle Measurement Tool
Final rule · Food and Drug Administration · 21 CFR part 888 · Opens the Federal Register
- July 23, 2026Revocation of the Color Additive Listing for Use of Orange B on Casings or Surfaces of Frankfurters and Sausages
Final rule · Food and Drug Administration · 21 CFR part 74 · Opens the Federal Register
- July 20, 2026Food Standards of Identity Modernization; Pasteurized Orange Juice
Final rule · Food and Drug Administration · 21 CFR part 146 · Opens the Federal Register
- July 7, 2026New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor
Final rule · Food and Drug Administration · Opens the Federal Register
- June 30, 2026Medical Devices; General and Plastic Surgery Devices; Classification of the Skin Patch for Treatment of Hyperhidrosis
Final rule · Food and Drug Administration · 21 CFR part 878 · Opens the Federal Register
- June 30, 2026Medical Devices; Anesthesiology Devices; Classification of the Monitor for Opioid Induced Impairment of Oxygenation
Final rule · Food and Drug Administration · 21 CFR part 868 · Opens the Federal Register
- June 29, 2026Medical Devices; Orthopedic Devices; Classification of the Medial Knee Implanted Shock Absorber
Final rule · Food and Drug Administration · 21 CFR part 888 · Opens the Federal Register
- June 26, 2026Medical Devices; General Hospital and Personal Use Devices; Classification of the Foam or Gel Chemical Sterilant/High Level Disinfectant
Final rule · Food and Drug Administration · 21 CFR part 880 · Opens the Federal Register
- June 26, 2026Medical Devices; Clinical Chemistry and Toxicology Devices; Classification of the Prognostic Test for Development or Progression of Preeclampsia
Final rule · Food and Drug Administration · 21 CFR part 862 · Opens the Federal Register
- June 26, 2026Medical Devices; Neurological Devices; Classification of the Computerized Behavioral Therapy Device for the Treatment of Fibromyalgia Symptoms
Final rule · Food and Drug Administration · 21 CFR part 882 · Opens the Federal Register
- June 26, 2026Medical Devices; Immunology and Microbiology Devices; Classification of the SARS-CoV-2 Serology Test
Final rule · Food and Drug Administration · 21 CFR part 866 · Opens the Federal Register
- June 26, 2026Medical Devices; General and Plastic Surgery Devices; Classification of the Breast Implant Suction Retrieval System
Final rule · Food and Drug Administration · 21 CFR part 878 · Opens the Federal Register
- June 26, 2026Medical Devices; Neurological Devices; Classification of the External Lower Extremity Nerve Stimulator for Restless Legs Syndrome
Final rule · Food and Drug Administration · 21 CFR part 882 · Opens the Federal Register
- June 26, 2026Medical Devices; General Hospital and Personal Use Devices; Classification of the Infant Supine Sleep System
Final rule · Food and Drug Administration · 21 CFR part 880 · Opens the Federal Register
- June 22, 2026Medical 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
Final rule · Food and Drug Administration · 21 CFR part 866 · Opens the Federal Register
- June 22, 2026Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Light-Projecting Measuring Device
Final rule · Food and Drug Administration · 21 CFR part 876 · Opens the Federal Register
- June 22, 2026Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Traction Device
Final rule · Food and Drug Administration · 21 CFR part 876 · Opens the Federal Register
- June 17, 2026Medical Devices; Gastroenterology-Urology Devices; Classification of the Ingestible Gastrointestinal Blood Detection Capsule
Final rule · Food and Drug Administration · 21 CFR part 876 · Opens the Federal Register
- June 17, 2026Medical Devices; Radiology Devices; Classification of the Radiological Machine Learning-Based Quantitative Imaging Software With Predetermined Change Control Plan
Final rule · Food and Drug Administration · 21 CFR part 892 · Opens the Federal Register
- June 15, 2026Amendment and Revocation of Organizational Information Regulations
Final rule · Food and Drug Administration · 21 CFR part 5 · Opens the Federal Register
- June 11, 2026Medical 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
Final rule · Food and Drug Administration · 21 CFR part 866 · Opens the Federal Register
- June 11, 2026Medical Devices; Immunology and Microbiology Devices; Classification of the Spinal Muscular Atrophy Newborn Screening Test System
Final rule · Food and Drug Administration · 21 CFR part 866 · Opens the Federal Register
- June 10, 2026Medical Devices; Ear, Nose, and Throat Devices; Classification of the Combined Acoustic and Electrical External Stimulation Device for the Relief of Tinnitus
Final rule · Food and Drug Administration · 21 CFR part 874 · Opens the Federal Register
- June 5, 2026Medical Devices; Orthopedic Devices; Classification of the Absorbable Metallic Bone Fixation Fastener
Final rule · Food and Drug Administration · 21 CFR part 888 · Opens the Federal Register
- June 5, 2026Medical Devices; Orthopedic Devices; Classification of the Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented or Uncemented Prosthesis
Final rule · Food and Drug Administration · 21 CFR part 888 · Opens the Federal Register
- June 5, 2026Medical Devices; Orthopedic Devices; Classification of the Resorbable Calcium Salt Bone Void Filler Containing a Single Approved Aminoglycoside Antibacterial
Final rule · Food and Drug Administration · 21 CFR part 888 · Opens the Federal Register
- June 1, 2026Medical Devices; Ear, Nose, and Throat Devices; Classification of the Oropharyngeal Electrical Stimulator
Final rule · Food and Drug Administration · 21 CFR part 874 · Opens the Federal Register
- June 1, 2026Medical Devices; Hematology and Pathology Devices; Classification of the Von Willebrand Factor Assay
Final rule · Food and Drug Administration · 21 CFR part 864 · Opens the Federal Register
- June 1, 2026Medical Devices; Dental Devices; Classification of the Intraoral Cooling Device
Final rule · Food and Drug Administration · 21 CFR part 872 · Opens the Federal Register
- June 1, 2026Medical Devices; Gastroenterology-Urology Devices; Classification of the Orally Ingested Transient Device for Constipation
Final rule · Food and Drug Administration · 21 CFR part 876 · Opens the Federal Register
- June 1, 2026Medical Devices; Anesthesiology Devices; Classification of the Adjunctive Pain Measurement Device for Anesthesiology
Final rule · Food and Drug Administration · 21 CFR part 868 · Opens the Federal Register
- June 1, 2026Medical Devices; Anesthesiology Devices; Classification of the Real-Time Ultrasound Anatomy Visualization and Labeling Device for Ultrasound Guided Regional Anesthesia
Final rule · Food and Drug Administration · 21 CFR part 868 · Opens the Federal Register
- June 1, 2026Medical Devices; General Hospital and Personal Use Devices; Classification of the Rigid Sterilization Container With Electronic Monitoring
Final rule · Food and Drug Administration · 21 CFR part 880 · Opens the Federal Register
- May 29, 2026Medical Devices; Neurological Devices; Classification of the Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms
Final rule · Food and Drug Administration · 21 CFR part 882 · Opens the Federal Register
- May 28, 2026Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Suturing Device for Altering Gastric Anatomy for Weight Loss
Final rule · Food and Drug Administration · 21 CFR part 876 · Opens the Federal Register
- May 12, 2026Medical 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
Final rule · Food and Drug Administration · 21 CFR part 866 · Opens the Federal Register
- May 8, 2026Medical Devices; Obstetrical and Gynecological Devices; Classification of the External Condom for Anal Intercourse or Vaginal Intercourse
Final rule · Food and Drug Administration · 21 CFR part 884 · Opens the Federal Register
- May 6, 2026Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Preserve and Stabilize Relative Abundances of Microbial Nucleic Acids in Clinical Samples
Final rule · Food and Drug Administration · 21 CFR part 866 · Opens the Federal Register
- May 6, 2026Medical Devices; Immunology and Microbiology Devices; Classification of the Circulating Tumor Cell Enrichment Device
Final rule · Food and Drug Administration · 21 CFR part 866 · Opens the Federal Register
- May 6, 2026Medical Devices; Ophthalmic Devices; Classification of the Corneal Storage Medium With Preservatives Including Antifungals
Final rule · Food and Drug Administration · 21 CFR part 886 · Opens the Federal Register
- May 1, 2026Medical Devices; General and Plastic Surgery Devices; Classification of the Phototherapy Device for Reducing the Appearance of Acute Post-Surgical Incisions
Final rule · Food and Drug Administration · 21 CFR part 878 · Opens the Federal Register
- April 30, 2026Medical Devices; Radiology Devices; Classification of the Radiation Therapy Marking Device
Final rule · Food and Drug Administration · 21 CFR part 892 · Opens the Federal Register
- April 30, 2026Medical Devices; Neurological Devices; Classification of the Brain Temperature Measurement System
Final rule · Food and Drug Administration · 21 CFR part 882 · Opens the Federal Register
- April 30, 2026Medical Devices; Cardiovascular Devices; Classification of the Laser-Powered Inferior Vena Cava Filter Retrieval Catheter
Final rule · Food and Drug Administration · 21 CFR part 870 · Opens the Federal Register
- April 22, 2026Medical Devices; Immunology and Microbiology Devices; Classification of the Alzheimer's Disease Pathology Assessment Test
Final rule · Food and Drug Administration · 21 CFR part 866 · Opens the Federal Register
- April 22, 2026Medical Devices; Ophthalmic Devices; Classification of the Digital Therapy Device for Amblyopia
Final rule · Food and Drug Administration · 21 CFR part 882 · Opens the Federal Register
- April 22, 2026Medical Devices; Anesthesiology Devices; Classification of the Device for Sleep Apnea Testing Based on Mandibular Movement
Final rule · Food and Drug Administration · 21 CFR part 868 · Opens the Federal Register
- April 22, 2026Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Setmelanotide Eligibility Gene Variant Detection System
Final rule · Food and Drug Administration · 21 CFR part 862 · Opens the Federal Register
- April 16, 2026Medical Devices; Ear, Nose, and Throat Devices; Classification of the Transcutaneous Electrical Nerve Stimulator for the Relief of Congestion
Final rule · Food and Drug Administration · 21 CFR part 874 · Opens the Federal Register
- April 16, 2026Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators
Final rule · Food and Drug Administration · 21 CFR part 890 · Opens the Federal Register
- April 16, 2026Medical Devices; Orthopedic Devices; Classification of the Manual Surgical Instrument for Appropriate Patient Selection for Orthopedic Implant
Final rule · Food and Drug Administration · 21 CFR part 888 · Opens the Federal Register
- April 16, 2026New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor Address
Final rule · Food and Drug Administration · 21 CFR parts 510, 516, 520 and 3 more · Opens the Federal Register
- March 25, 2026General 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
Final rule · Food and Drug Administration · 21 CFR part 878 · Opens the Federal Register
- March 5, 2026Revising the National Drug Code Format and Drug Label Barcode Requirements
Final rule · Food and Drug Administration · 21 CFR parts 201, 207 · Opens the Federal Register
- Feb. 19, 2026Revocation of Methods of Analysis Regulation
Final rule · Food and Drug Administration · 21 CFR part 2 · Opens the Federal Register
- Feb. 19, 2026Revocation 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
Final rule · Food and Drug Administration · 21 CFR part 26 · Opens the Federal Register
- Feb. 6, 2026Listing of Color Additives Exempt From Certification; Beetroot Red
Final rule · Food and Drug Administration · 21 CFR part 73 · Opens the Federal Register
- Feb. 6, 2026Listing of Color Additives Exempt From Certification; Spirulina Extract
Final rule · Food and Drug Administration · 21 CFR part 73 · Opens the Federal Register
- Feb. 6, 2026New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor Address
Final rule · Food and Drug Administration · 21 CFR parts 516, 520, 522 and 3 more · Opens the Federal Register
- Dec. 19, 2025Medical Devices; Neurological Devices; Classification of the Electrical Tongue Nerve Stimulator To Treat Motor Deficits
Final rule · Food and Drug Administration · 21 CFR part 882 · Opens the Federal Register
- Dec. 4, 2025Medical Devices; Quality Management System Regulation Technical Amendments
Final rule · Food and Drug Administration · 21 CFR parts 801, 803, 812 and 15 more · Opens the Federal Register
- Nov. 26, 2025Medical Devices; Gastroenterology-Urology Devices; Classification of the Anchored Esophageal Sheath
Final rule · Food and Drug Administration · 21 CFR part 876 · Opens the Federal Register
- Nov. 26, 2025Medical Devices; Neurological Devices; Classification of Field Generator Positioning Device
Final rule · Food and Drug Administration · 21 CFR part 882 · Opens the Federal Register
- Oct. 1, 2025Listing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue; Confirmation of Effective Date
Final rule · Food and Drug Administration · 21 CFR part 73 · Opens the Federal Register
- Sept. 26, 2025Revocation of Food Standards for 11 Products Not Currently Sold; Confirmation of Effective Date
Final rule · Food and Drug Administration · 21 CFR parts 145, 155 · Opens the Federal Register
- Sept. 25, 2025Prior 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
Final rule · Food and Drug Administration · 21 CFR part 1 · Opens the Federal Register
- Sept. 19, 2025Regulation Identification Number 0910-AJ05 Medical Devices; Laboratory Developed Tests; Implementation of Vacatur
Final rule · Food and Drug Administration · 21 CFR part 809 · Opens the Federal Register
- Sept. 18, 2025Radiological Health Regulations; Technical Amendments
Final rule · Food and Drug Administration · 21 CFR part 1010 · Opens the Federal Register
- Sept. 18, 2025Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices
Final rule · Food and Drug Administration · 21 CFR part 866 · Opens the Federal Register
- Sept. 4, 2025Food 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
Final rule · Food and Drug Administration · 21 CFR part 172 · Opens the Federal Register
- Sept. 3, 2025Secondary Direct Food Additives Permitted in Food for Human Consumption; Hydrogen Peroxide
Final rule · Food and Drug Administration · 21 CFR part 173 · Opens the Federal Register
- Aug. 29, 2025Advisory Committee; Arthritis Advisory Committee; Termination; Removal From List of Standing Committees
Final rule · Food and Drug Administration · 21 CFR part 14 · Opens the Federal Register
- Aug. 22, 2025New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address
Final rule · Food and Drug Administration · 21 CFR parts 510, 520, 522 and 3 more · Opens the Federal Register
- Aug. 21, 2025Medical Devices; Immunology and Microbiology Devices; Classification of the Device That Detects Nucleic Acid Sequences From Microorganisms Associated With Vaginitis and Bacterial Vaginosis
Final rule · Food and Drug Administration · 21 CFR part 866 · Opens the Federal Register
- Aug. 21, 2025Medical Devices; Immunology and Microbiology Devices; Classification of the Anti-Phospholipase A2 Receptor Immunological Test System
Final rule · Food and Drug Administration · 21 CFR part 866 · Opens the Federal Register
- Aug. 21, 2025Medical Devices; Immunology and Microbiology Devices; Classification of the Postnatal Chromosomal Copy Number Variation Detection System
Final rule · Food and Drug Administration · 21 CFR part 866 · Opens the Federal Register
- Aug. 21, 2025Medical Devices; Radiology Devices; Classification of the Liver Iron Concentration Imaging Companion Diagnostic for Deferasirox
Final rule · Food and Drug Administration · 21 CFR part 892 · Opens the Federal Register
- Aug. 21, 2025Medical 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
Final rule · Food and Drug Administration · 21 CFR part 866 · Opens the Federal Register
- Aug. 21, 2025Medical Devices; Immunology and Microbiology Devices; Classification of the Cancer Predisposition Risk Assessment System
Final rule · Food and Drug Administration · 21 CFR part 866 · Opens the Federal Register
- Aug. 21, 2025Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Menopause Test System
Final rule · Food and Drug Administration · 21 CFR part 862 · Opens the Federal Register
- Aug. 21, 2025Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Pharmacogenetic Assessment System
Final rule · Food and Drug Administration · 21 CFR part 862 · Opens the Federal Register
- Aug. 21, 2025Medical Devices; Immunology and Microbiology Devices; Classification of the Mutation Detection Test for Myeloproliferative Neoplasms
Final rule · Food and Drug Administration · 21 CFR part 866 · Opens the Federal Register
- Aug. 21, 2025Medical Devices; Orthopedic Devices; Classification of Orthopedic Manual Surgical Instrumentation for Use With Total Disc Replacement Devices
Final rule · Food and Drug Administration · 21 CFR part 888 · Opens the Federal Register
- Aug. 21, 2025Medical Devices; Orthopedic Devices; Classification of Orthopedic Manual Surgical Instrumentation for Use With Non-Fusion Spinous Process Spacer Devices
Final rule · Food and Drug Administration · 21 CFR part 888 · Opens the Federal Register
- Aug. 21, 2025Medical Devices; Gastroenterology-Urology Devices; Classification of the Laparoscopic Gastrointestinal Sizing Tool
Final rule · Food and Drug Administration · 21 CFR part 876 · Opens the Federal Register
- Aug. 21, 2025Listing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract; Confirmation of Effective Date
Final rule · Food and Drug Administration · 21 CFR part 73 · Opens the Federal Register
- Aug. 21, 2025Listing of Color Additives Exempt From Certification; Galdieria Extract Blue; Confirmation of Effective Date
Final rule · Food and Drug Administration · 21 CFR part 73 · Opens the Federal Register
- Aug. 21, 2025Listing of Color Additives Exempt From Certification; Calcium Phosphate; Confirmation of Effective Date
Final rule · Food and Drug Administration · 21 CFR part 73 · Opens the Federal Register
- July 28, 2025Regulatory Hearing Before the Food and Drug Administration
Final rule · Food and Drug Administration · 21 CFR part 16 · Opens the Federal Register
- July 17, 2025Revocation of Food Standards for 11 Products Not Currently Sold
Final rule · Food and Drug Administration · 21 CFR parts 145, 155 · Opens the Federal Register
- July 15, 2025Listing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue
Final rule · Food and Drug Administration · 21 CFR part 73 · Opens the Federal Register
- June 26, 2025Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Lysosomal Storage Disorder Newborn Screening Test System
Final rule · Food and Drug Administration · 21 CFR part 862 · Opens the Federal Register
- June 26, 2025Medical Devices; Radiology Devices; Classification of the Cream for X-Ray Attenuation
Final rule · Food and Drug Administration · 21 CFR part 892 · Opens the Federal Register
- June 26, 2025Medical Devices; Hematology and Pathology Devices; Classification of the Fluorescence In Situ Hybridization-Based Detection of Chromosomal Abnormalities From Patients With Hematologic Malignancies
Final rule · Food and Drug Administration · 21 CFR part 864 · Opens the Federal Register
- June 26, 2025Medical Devices; Immunology and Microbiology Devices; Classification of the Herpes Simplex Virus Nucleic Acid-Based Assay for Central Nervous System Infections
Final rule · Food and Drug Administration · 21 CFR part 866 · Opens the Federal Register
- June 26, 2025Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Muscular Dystrophy Newborn Screening Test
Final rule · Food and Drug Administration · 21 CFR part 862 · Opens the Federal Register
- June 18, 2025Medical Devices; Exemptions From Premarket Notification: Class II Devices; Clinical Electronic Thermometers
Final rule · Food and Drug Administration · 21 CFR part 880 · Opens the Federal Register
- June 13, 2025Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Fungal Nucleic Acids Directly in Respiratory Specimens
Final rule · Food and Drug Administration · 21 CFR part 866 · Opens the Federal Register
- June 13, 2025Medical Devices; Immunology and Microbiology Devices; Classification of the Cellular Analysis System for Multiplexed Antimicrobial Susceptibility Testing
Final rule · Food and Drug Administration · 21 CFR part 866 · Opens the Federal Register
- June 13, 2025Medical Devices; Immunology and Microbiology Devices; Classification of the Clinical Mass Spectrometry Microorganism Identification and Differentiation System
Final rule · Food and Drug Administration · 21 CFR part 866 · Opens the Federal Register
- June 13, 2025Medical Devices; Radiology Devices; Classification of the Radiological Computer-Assisted Detection and Diagnosis Software
Final rule · Food and Drug Administration · 21 CFR part 892 · Opens the Federal Register
- June 2, 2025Medical Devices; Radiology Devices; Classification of the Radiological Acquisition and/or Optimization Guidance System
Final rule · Food and Drug Administration · 21 CFR part 892 · Opens the Federal Register
- June 2, 2025Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect Bacterial Protease Activity in Chronic Wound Fluid
Final rule · Food and Drug Administration · 21 CFR part 866 · Opens the Federal Register
- May 30, 2025Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Anti-Mullerian Hormone Test System
Final rule · Food and Drug Administration · 21 CFR part 862 · Opens the Federal Register
- May 29, 2025Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Plazomicin Test System
Final rule · Food and Drug Administration · 21 CFR part 862 · Opens the Federal Register
- May 29, 2025Medical Devices; Immunology and Microbiology Devices; Classification of the Zika Virus Serological Reagents
Final rule · Food and Drug Administration · 21 CFR part 866 · Opens the Federal Register
- May 29, 2025Medical Devices; Gastroenterology-Urology Devices; Classification of the Temporarily-Placed Urethral Opening System for Symptoms of Benign Prostatic Hyperplasia
Final rule · Food and Drug Administration · 21 CFR part 876 · Opens the Federal Register
- May 29, 2025Medical Devices; Immunology and Microbiology Devices; Classification of the Inherited Nucleotide Repeat Disorder Deoxyribonucleic Acid Test
Final rule · Food and Drug Administration · 21 CFR part 866 · Opens the Federal Register
- May 29, 2025Listing of Color Additives; Myoglobin; Confirmation of Effective Date
Final rule · Food and Drug Administration · 21 CFR part 73 · Opens the Federal Register
- May 19, 2025Food Additives Permitted in Feed and Drinking Water of Animals; Selenium
Final rule · Food and Drug Administration · 21 CFR part 573 · Opens the Federal Register
- May 12, 2025Listing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract
Final rule · Food and Drug Administration · 21 CFR part 73 · Opens the Federal Register
- May 12, 2025Listing of Color Additives Exempt From Certification; Calcium Phosphate
Final rule · Food and Drug Administration · 21 CFR part 73 · Opens the Federal Register
- May 12, 2025Listing of Color Additives Exempt From Certification; Galdieria Extract Blue
Final rule · Food and Drug Administration · 21 CFR part 73 · Opens the Federal Register
- May 9, 2025New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor
Final rule · Food and Drug Administration · 21 CFR parts 510, 516, 520 and 2 more · Opens the Federal Register
- May 9, 2025Medical Devices; Immunology and Microbiology Devices; Classification of the DNA-Based Test To Measure Minimal Residual Disease in Hematological Malignancies
Final rule · Food and Drug Administration · 21 CFR part 866 · Opens the Federal Register
- May 9, 2025Medical 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
Final rule · Food and Drug Administration · 21 CFR part 866 · Opens the Federal Register
- May 9, 2025Medical Devices; Immunology and Microbiology Devices; Classification of the Microbial Nucleic Acid Storage and Stabilization Device
Final rule · Food and Drug Administration · 21 CFR part 866 · Opens the Federal Register
- May 9, 2025Medical Devices; Immunology and Microbiology Devices; Classification of the Cytomegalovirus Nucleic Acid Detection Device for Congenital Cytomegalovirus Infection
Final rule · Food and Drug Administration · 21 CFR part 866 · Opens the Federal Register
- May 9, 2025Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Breast Milk Macronutrients Test System
Final rule · Food and Drug Administration · 21 CFR part 862 · Opens the Federal Register
- May 9, 2025Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Voriconazole Test System
Final rule · Food and Drug Administration · 21 CFR part 862 · Opens the Federal Register
- May 9, 2025Medical 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)
Final rule · Food and Drug Administration · 21 CFR part 866 · Opens the Federal Register
- May 9, 2025Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microbial Nucleic Acids by Fluorescence In Situ Hybridization in Clinical Specimens
Final rule · Food and Drug Administration · 21 CFR part 866 · Opens the Federal Register
- May 9, 2025Medical Devices; Hematology and Pathology Devices; Classification of the Coagulation System for the Measurement of Whole Blood Viscoelastic Properties in Perioperative Patients
Final rule · Food and Drug Administration · 21 CFR part 864 · Opens the Federal Register
- Jan. 21, 2025New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address
Final rule · Food and Drug Administration · 21 CFR parts 510, 520, 522 and 3 more · Opens the Federal Register
- Jan. 17, 2025Listing of Color Additives Exempt From Certification; Myoglobin
Final rule · Food and Drug Administration · 21 CFR part 73 · Opens the Federal Register
- Jan. 16, 2025Color 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
Final rule · Food and Drug Administration · 21 CFR part 74 · Opens the Federal Register
- Jan. 6, 2025Considerations for Complying With 21 CFR 211.110; Draft Guidance for Industry; Availability
Final rule · Food and Drug Administration · 21 CFR part 211 · Opens the Federal Register
Proposed rules 43
- Nov. 2, 2026Infant Formula Nutrient Requirements
Proposed rule · Food and Drug Administration · 21 CFR parts 107, 184
- Oct. 23, 2026Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability
Proposed rule · Food and Drug Administration · 21 CFR part 117
- Oct. 23, 2026
- Oct. 9, 2026
- Sept. 25, 2026Filing 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
Proposed rule · Food and Drug Administration · 21 CFR part 73 · Opens the Federal Register
- Sept. 22, 2026Nonclinical Testing Terminology
Proposed rule · Food and Drug Administration · 21 CFR parts 312, 314, 315 and 2 more · Opens the Federal Register
- Aug. 19, 2026GNT USA, LLC.; Filing of Color Additive Petition
Proposed rule · Food and Drug Administration · 21 CFR part 73 · Opens the Federal Register
- Aug. 19, 2026International Association of Color Manufacturers; Filing of Color Additive Petition
Proposed rule · Food and Drug Administration · 21 CFR part 73 · Opens the Federal Register
- Aug. 19, 2026Gardenia Blue Interest Group; Filing of Color Additive Petition
Proposed rule · Food and Drug Administration · 21 CFR part 73 · Opens the Federal Register
- Aug. 17, 2026Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer
Proposed rule · Food and Drug Administration · 21 CFR part 876 · Opens the Federal Register
- Aug. 17, 2026Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments
Proposed rule · Food and Drug Administration · 21 CFR parts 870, 876, 878 · Opens the Federal Register
- Aug. 11, 2026Substances Generally Recognized as Safe
Proposed rule · Food and Drug Administration · 21 CFR parts 170, 570 · Opens the Federal Register
- Aug. 10, 2026Radiology Devices; Reclassification of Digital Breast Tomosynthesis System
Proposed rule · Food and Drug Administration · 21 CFR part 892 · Opens the Federal Register
- July 24, 2026Evonik Corporation, Filing of Food Additive Petition (Animal Use)
Proposed rule · Food and Drug Administration · 21 CFR part 573 · Opens the Federal Register
- July 23, 2026Proposal To Revoke the Color Additive Listing for Use of Citrus Red No. 2 on the Skins of Mature Oranges
Proposed rule · Food and Drug Administration · 21 CFR part 74 · Opens the Federal Register
- July 13, 2026Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
Proposed rule · Food and Drug Administration · 21 CFR part 207 · Opens the Federal Register
- June 29, 2026Establishment Registration and Product Listing for Tobacco Products
Proposed rule · Food and Drug Administration · 21 CFR part 1108 · Opens the Federal Register
- June 25, 2026Sterigenics U.S., LLC; Filing of Food Additive Petition
Proposed rule · Food and Drug Administration · 21 CFR part 179 · Opens the Federal Register
- May 6, 2026Modification of Certain Terminology in Title 21
Proposed rule · Food and Drug Administration · 21 CFR parts 10, 56, 106 and 13 more · Opens the Federal Register
- April 1, 2026Filing 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
Proposed rule · Food and Drug Administration · 21 CFR part 73 · Opens the Federal Register
- March 30, 2026Microbiology Devices; Reclassification of Mycobacterium Tuberculosis Cell-Mediated Immunity Tests and Immune Response Enzyme-Linked Immunospot Tests
Proposed rule · Food and Drug Administration · 21 CFR part 866 · Opens the Federal Register
- March 18, 2026Medical Devices; Radiology Devices; Classification of Blood Irradiators
Proposed rule · Food and Drug Administration · 21 CFR part 892 · Opens the Federal Register
- March 18, 2026Effective Date of Requirement for Premarket Approval Applications for Blood Irradiators Intended To Prevent Metastasis
Proposed rule · Food and Drug Administration · 21 CFR part 892 · Opens the Federal Register
- March 4, 2026Kemin Industries, Inc.; Filing of Food Additive Petition (Animal Use)
Proposed rule · Food and Drug Administration · 21 CFR part 573 · Opens the Federal Register
- March 4, 2026Ecoflora Cares; Filing of Color Additive Petition
Proposed rule · Food and Drug Administration · 21 CFR part 73 · Opens the Federal Register
- Nov. 26, 2025Green Innovation GmbH; Filing of Food Additive Petition (Animal Use)
Proposed rule · Food and Drug Administration · 21 CFR part 573 · Opens the Federal Register
- Nov. 25, 2025Immunology 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
Proposed rule · Food and Drug Administration · 21 CFR part 866 · Opens the Federal Register
- Sept. 17, 2025Proposal To Remove the Color Additive Listing for Use of Orange B on Casings or Surfaces of Frankfurters and Sausages
Proposed rule · Food and Drug Administration · 21 CFR part 74 · Opens the Federal Register
- Sept. 3, 2025Biomin GmbH; Filing of Food Additive Petition (Animal Use)
Proposed rule · Food and Drug Administration · 21 CFR part 573 · Opens the Federal Register
- Aug. 19, 2025Evonik Corporation; Filing of Food Additive Petition (Animal Use)
Proposed rule · Food and Drug Administration · 21 CFR part 573 · Opens the Federal Register
- Aug. 14, 2025Food Standards of Identity Modernization; Pasteurized Orange Juice; Proposed Rule; Correction
Proposed rule · Food and Drug Administration · 21 CFR part 146 · Opens the Federal Register
- Aug. 7, 2025Requirements for Additional Traceability Records for Certain Foods: Compliance Date Extension
Proposed rule · Food and Drug Administration · 21 CFR part 1 · Opens the Federal Register
- Aug. 6, 2025Food Standards of Identity Modernization; Pasteurized Orange Juice
Proposed rule · Food and Drug Administration · 21 CFR part 146 · Opens the Federal Register
- July 29, 2025APIX Biosciences US LLC; Filing of Food Additive Petition (Animal Use)
Proposed rule · Food and Drug Administration · 21 CFR part 573 · Opens the Federal Register
- July 29, 2025Spoonbill Foundation; Filing of Food Additive Petition
Proposed rule · Food and Drug Administration · 21 CFR part 172 · Opens the Federal Register
- July 17, 2025Proposal To Revoke 23 Standards of Identity for Foods
Proposed rule · Food and Drug Administration · 21 CFR parts 136, 139, 146 and 2 more · Opens the Federal Register
- July 17, 2025Revocation of Food Standards for 11 Products Not Currently Sold
Proposed rule · Food and Drug Administration · 21 CFR parts 145, 155 · Opens the Federal Register
- July 17, 2025Proposal To Revoke 18 Standards of Identity for Dairy Products
Proposed rule · Food and Drug Administration · 21 CFR parts 131, 133, 135 and 1 more · Opens the Federal Register
- June 11, 2025Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product
Proposed rule · Food and Drug Administration · 21 CFR part 864 · Opens the Federal Register
- March 14, 2025Impossible Foods, Inc.; Filing of Color Additive Petition
Proposed rule · Food and Drug Administration · 21 CFR part 73 · Opens the Federal Register
- Jan. 16, 2025Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products
Proposed rule · Food and Drug Administration · 21 CFR part 1160 · Opens the Federal Register
- Jan. 16, 2025Food Labeling: Front-of-Package Nutrition Information
Proposed rule · Food and Drug Administration · 21 CFR part 101 · Opens the Federal Register
- Jan. 7, 2025Establishing Sanitation Programs for Low-Moisture Ready-To-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event; Draft Guidance for Industry; Availability
Proposed rule · Food and Drug Administration · 21 CFR parts 106, 117 · Opens the Federal Register