Federal rules on medical devices: 198 since January 2024

Name: Federal rules on medical devices: 198 since January 2024
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

178 final rules and 20 proposed rules since January 23, 2024, 13 of them marked significant. Most come from the Food and Drug Administration (165), Centers for Medicare & Medicaid Services (16), Veterans Affairs Department (9), Nuclear Regulatory Commission (3).

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Document	Agency	Type	Published
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	Food and Drug Administration	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	Food and Drug Administration	Final rule	Oct 9
Medical Devices; Immunology and Microbiology Devices; Classification of the Hematopoietic Cell Enrichment Kit 2026-20725	Food and Drug Administration	Final rule	Oct 9
Medical Devices; Exemptions From Premarket Notification: Class II Devices; Certain Clinical Toxicology Test Systems 2026-20448	Food and Drug Administration	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	Food and Drug Administration	Final rule	Oct 6
Medical Devices; Cardiovascular Devices; Classification of the Hyperoxia Monitoring Device Adjunct to Pulse Oximetry 2026-20441	Food and Drug Administration	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	Food and Drug Administration	Final rule	Oct 6
Medical Devices; Gastroenterology-Urology Devices; Classification of the Flushing and Storage Solution for Vascular Autografts at Room Temperature 2026-20075	Food and Drug Administration	Final rule	Sep 30
Medical Devices; Cardiovascular Devices; Classification of the Cardiovascular Machine Learning-Based Notification Software 2026-18612	Food and Drug Administration	Final rule	Sep 11
Medical Devices; Cardiovascular Devices; Classification of the Mechanical Deviation Device for Esophageal Protection During Cardiac Ablation Procedures 2026-18433	Food and Drug Administration	Final rule	Sep 10
Medical Devices; Cardiovascular Devices; Classification of the Temperature Regulation Device for Esophageal Protection During Cardiac Ablation Procedures 2026-18432	Food and Drug Administration	Final rule	Sep 10
Medical Devices; Cardiovascular Devices; Classification of the Extravascular Support for an Arteriovenous Fistula for Vascular Access 2026-18431	Food and Drug Administration	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	Food and Drug Administration	Final rule	Sep 10
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Cooperative Powered Surgical Assist Device for ENT Surgery 2026-18429	Food and Drug Administration	Final rule	Sep 10
Medical Devices; Gastroenterology-Urology Devices; Classification of the Implanted Tibial Electrical Urinary Continence Device 2026-18428	Food and Drug Administration	Final rule	Sep 10
Medical Devices; Radiology Devices; Classification of the Vaginal Hydrogel Packing System 2026-18427	Food and Drug Administration	Final rule	Sep 10
Medical Devices; General Hospital and Personal Use Devices; Classification of the Whole Room Microbial Reduction Device 2026-18426	Food and Drug Administration	Final rule	Sep 10
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	Food and Drug Administration	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	Food and Drug Administration	Final rule	Aug 17
Radiology Devices; Reclassification of Digital Breast Tomosynthesis System 2026-16209	Food and Drug Administration	Proposed rule	Aug 10
Medical Devices; Radiology Devices; Classification of the Fludeoxyglucose F18-Guided Radiation Therapy System 2026-15963	Food and Drug Administration	Final rule	Aug 6
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals (IPPS) and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year (FY) 2027 Rates; Requirements for Quality Programs; Other Policy Changes; and Adoption of Updated Versions of Certain Health Information Technology Standards 2026-15833	Centers for Medicare & Medicaid Services	Final rule	Aug 4
Medical Devices; Radiology Devices; Classification of the Phase-Changing Fiducial Marker for Radiation Therapy 2026-15303	Food and Drug Administration	Final rule	Jul 29
Rescission of Outdated Veterans Choice Program Regulations 2026-15210	Veterans Affairs Department	Final rule	Jul 28
Reducing Barriers to Medical Use Licensing 2026-15080	Nuclear Regulatory Commission	Proposed rule	Jul 27
Medical Devices; General Hospital and Personal Use Devices; Classification of the Active Noise Attenuation System for Infant Incubators 2026-15075	Food and Drug Administration	Final rule	Jul 27
Medical Devices; Gastroenterology-Urology Devices; Classification of the Non-Medicated Topical Formulation for Treatment of Erectile Dysfunction 2026-15074	Food and Drug Administration	Final rule	Jul 27
Medical Devices; Orthopedic Devices; Classification of the Intraoperative Surgical Angle Measurement Tool 2026-14987	Food and Drug Administration	Final rule	Jul 24
Medical Devices; General Hospital and Personal Use Devices; Classification of the Diabetes Digital Behavioral Therapeutic Device 2026-14986	Food and Drug Administration	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	Food and Drug Administration	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	Food and Drug Administration	Final rule	Jul 24
Medicare and Medicaid Programs; CY 2027 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program 2026-14327	Centers for Medicare & Medicaid Services	Proposed rule	Jul 16
Reforming and Modernizing the NRC's Radiation Protection Framework 2026-14208	Nuclear Regulatory Commission	Proposed rule	Jul 15
Expansion of VA Process for 72-Hour Notification of Emergency Treatment 2026-13971	Veterans Affairs Department	Final rule	Jul 10
Calendar Year 2027 Home Health Prospective Payment System (HH PPS) Rate Update; Requirements for the HH Quality Reporting Program and the Expanded HH Value-Based Purchasing Model; Medicare Provider Enrollment, Durable Medical Equipment (DME), and DME, Prosthetics, Orthotics, and Supplies (DMEPOS) Policies 2026-13602	Centers for Medicare & Medicaid Services	Proposed rule	Jul 6
Medical Devices; Anesthesiology Devices; Classification of the Monitor for Opioid Induced Impairment of Oxygenation 2026-13140	Food and Drug Administration	Final rule	Jun 30
Medical Devices; General and Plastic Surgery Devices; Classification of the Skin Patch for Treatment of Hyperhidrosis 2026-13139	Food and Drug Administration	Final rule	Jun 30
Medical Devices; Orthopedic Devices; Classification of the Medial Knee Implanted Shock Absorber 2026-13101	Food and Drug Administration	Final rule	Jun 29
Medical Devices; General Hospital and Personal Use Devices; Classification of the Infant Supine Sleep System 2026-12905	Food and Drug Administration	Final rule	Jun 26
Medical Devices; Neurological Devices; Classification of the External Lower Extremity Nerve Stimulator for Restless Legs Syndrome 2026-12904	Food and Drug Administration	Final rule	Jun 26
Medical Devices; General and Plastic Surgery Devices; Classification of the Breast Implant Suction Retrieval System 2026-12903	Food and Drug Administration	Final rule	Jun 26
Medical Devices; Immunology and Microbiology Devices; Classification of the SARS-CoV-2 Serology Test 2026-12902	Food and Drug Administration	Final rule	Jun 26
Medical Devices; Neurological Devices; Classification of the Computerized Behavioral Therapy Device for the Treatment of Fibromyalgia Symptoms 2026-12901	Food and Drug Administration	Final rule	Jun 26
Medical Devices; Clinical Chemistry and Toxicology Devices; Classification of the Prognostic Test for Development or Progression of Preeclampsia 2026-12900	Food and Drug Administration	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	Food and Drug Administration	Final rule	Jun 26
Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Traction Device 2026-12445	Food and Drug Administration	Final rule	Jun 22
Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Light-Projecting Measuring Device 2026-12444	Food and Drug Administration	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	Food and Drug Administration	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	Food and Drug Administration	Final rule	Jun 17
Medical Devices; Gastroenterology-Urology Devices; Classification of the Ingestible Gastrointestinal Blood Detection Capsule 2026-12165	Food and Drug Administration	Final rule	Jun 17
Medical Devices; Immunology and Microbiology Devices; Classification of the Spinal Muscular Atrophy Newborn Screening Test System 2026-11740	Food and Drug Administration	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	Food and Drug Administration	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	Food and Drug Administration	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	Food and Drug Administration	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	Food and Drug Administration	Final rule	Jun 5
Medical Devices; Orthopedic Devices; Classification of the Absorbable Metallic Bone Fixation Fastener 2026-11302	Food and Drug Administration	Final rule	Jun 5
Medical Devices; General Hospital and Personal Use Devices; Classification of the Rigid Sterilization Container With Electronic Monitoring 2026-10908	Food and Drug Administration	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	Food and Drug Administration	Final rule	Jun 1
Medical Devices; Anesthesiology Devices; Classification of the Adjunctive Pain Measurement Device for Anesthesiology 2026-10905	Food and Drug Administration	Final rule	Jun 1
Medical Devices; Gastroenterology-Urology Devices; Classification of the Orally Ingested Transient Device for Constipation 2026-10904	Food and Drug Administration	Final rule	Jun 1
Medical Devices; Dental Devices; Classification of the Intraoral Cooling Device 2026-10899	Food and Drug Administration	Final rule	Jun 1
Medical Devices; Hematology and Pathology Devices; Classification of the Von Willebrand Factor Assay 2026-10898	Food and Drug Administration	Final rule	Jun 1
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Oropharyngeal Electrical Stimulator 2026-10894	Food and Drug Administration	Final rule	Jun 1
Medical Devices; Neurological Devices; Classification of the Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms 2026-10675	Food and Drug Administration	Final rule	May 29
Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Suturing Device for Altering Gastric Anatomy for Weight Loss 2026-10621	Food and Drug Administration	Final 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	Food and Drug Administration	Final rule	May 12
Medical Devices; Obstetrical and Gynecological Devices; Classification of the External Condom for Anal Intercourse or Vaginal Intercourse 2026-09152	Food and Drug Administration	Final rule	May 8
Modification of Certain Terminology in Title 21 2026-08826	Food and Drug Administration	Proposed rule	May 6
Medical Devices; Ophthalmic Devices; Classification of the Corneal Storage Medium With Preservatives Including Antifungals 2026-08813	Food and Drug Administration	Final rule	May 6
Medical Devices; Immunology and Microbiology Devices; Classification of the Circulating Tumor Cell Enrichment Device 2026-08812	Food and Drug Administration	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	Food and Drug Administration	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	Food and Drug Administration	Final rule	May 1
Medical Devices; Cardiovascular Devices; Classification of the Laser-Powered Inferior Vena Cava Filter Retrieval Catheter 2026-08426	Food and Drug Administration	Final rule	Apr 30
Medical Devices; Neurological Devices; Classification of the Brain Temperature Measurement System 2026-08425	Food and Drug Administration	Final rule	Apr 30
Medical Devices; Radiology Devices; Classification of the Radiation Therapy Marking Device 2026-08424	Food and Drug Administration	Final rule	Apr 30
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Setmelanotide Eligibility Gene Variant Detection System 2026-07863	Food and Drug Administration	Final rule	Apr 22
Medical Devices; Anesthesiology Devices; Classification of the Device for Sleep Apnea Testing Based on Mandibular Movement 2026-07862	Food and Drug Administration	Final rule	Apr 22
Medical Devices; Ophthalmic Devices; Classification of the Digital Therapy Device for Amblyopia 2026-07861	Food and Drug Administration	Final rule	Apr 22
Medical Devices; Immunology and Microbiology Devices; Classification of the Alzheimer's Disease Pathology Assessment Test 2026-07860	Food and Drug Administration	Final rule	Apr 22
Medical Devices; Orthopedic Devices; Classification of the Manual Surgical Instrument for Appropriate Patient Selection for Orthopedic Implant 2026-07367	Food and Drug Administration	Final rule	Apr 16
Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators 2026-07366	Food and Drug Administration	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	Food and Drug Administration	Final rule	Apr 16
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals (IPPS) and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year (FY) 2027 Rates; Requirements for Quality Programs; and Other Policy Changes 2026-07203	Centers for Medicare & Medicaid Services	Proposed rule	Apr 14
Microbiology Devices; Reclassification of Mycobacterium Tuberculosis Cell-Mediated Immunity Tests and Immune Response Enzyme-Linked Immunospot Tests 2026-06064	Food and Drug Administration	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	Food and Drug Administration	Final rule	Mar 25
Effective Date of Requirement for Premarket Approval Applications for Blood Irradiators Intended To Prevent Metastasis 2026-05322	Food and Drug Administration	Proposed rule	Mar 18
Medical Devices; Radiology Devices; Classification of Blood Irradiators 2026-05320	Food and Drug Administration	Proposed rule	Mar 18
Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program; Correction 2026-04797 · significant	Centers for Medicare & Medicaid Services	Final rule	Mar 12
Listing of Color Additives Exempt From Certification; Spirulina Extract 2026-02314	Food and Drug Administration	Final rule	Feb 6
Listing of Color Additives Exempt From Certification; Beetroot Red 2026-02313	Food and Drug Administration	Final rule	Feb 6
Delete, Delete, Delete 2026-01442	Federal Communications Commission	Final rule	Jan 26
Medical Devices; Neurological Devices; Classification of the Electrical Tongue Nerve Stimulator To Treat Motor Deficits 2025-23413	Food and Drug Administration	Final rule	Dec 19, 2025
Medical Devices; Quality Management System Regulation Technical Amendments 2025-21955	Food and Drug Administration	Final rule	Dec 4, 2025
The Sunset Rule 2025-21784 · significant	Nuclear Regulatory Commission	Final rule	Dec 3, 2025
Medicare and Medicaid Programs; Calendar Year 2026 Home Health Prospective Payment System (HH PPS) Rate Update; Requirements for the HH Quality Reporting Program and the HH Value-Based Purchasing Expanded Model; Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program Updates; DMEPOS Accreditation Requirements; Provider Enrollment; and Other Medicare and Medicaid Policies 2025-21767 · significant	Centers for Medicare & Medicaid Services	Final rule	Dec 2, 2025
Medical Devices; Neurological Devices; Classification of Field Generator Positioning Device 2025-21218	Food and Drug Administration	Final rule	Nov 26, 2025
Medical Devices; Gastroenterology-Urology Devices; Classification of the Anchored Esophageal Sheath 2025-21217	Food and Drug Administration	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	Food and Drug Administration	Proposed rule	Nov 25, 2025
Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program 2025-19787 · significant	Centers for Medicare & Medicaid Services	Final rule	Nov 5, 2025
Health Care Professionals Practicing Via Telehealth 2025-19324 · significant	Veterans Affairs Department	Final rule	Oct 2, 2025
Listing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue; Confirmation of Effective Date 2025-19166	Food and Drug Administration	Final rule	Oct 1, 2025
Regulation Identification Number 0910-AJ05 Medical Devices; Laboratory Developed Tests; Implementation of Vacatur 2025-18239	Food and Drug Administration	Final rule	Sep 19, 2025
Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices 2025-18082	Food and Drug Administration	Final rule	Sep 18, 2025
Listing of Color Additives Exempt From Certification; Calcium Phosphate; Confirmation of Effective Date 2025-16047	Food and Drug Administration	Final rule	Aug 21, 2025
Listing of Color Additives Exempt From Certification; Galdieria Extract Blue; Confirmation of Effective Date 2025-16046	Food and Drug Administration	Final rule	Aug 21, 2025
Listing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract; Confirmation of Effective Date 2025-16045	Food and Drug Administration	Final rule	Aug 21, 2025
Medical Devices; Gastroenterology-Urology Devices; Classification of the Laparoscopic Gastrointestinal Sizing Tool 2025-16041	Food and Drug Administration	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	Food and Drug Administration	Final rule	Aug 21, 2025
Medical Devices; Orthopedic Devices; Classification of Orthopedic Manual Surgical Instrumentation for Use With Total Disc Replacement Devices 2025-16039	Food and Drug Administration	Final rule	Aug 21, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Mutation Detection Test for Myeloproliferative Neoplasms 2025-16038	Food and Drug Administration	Final rule	Aug 21, 2025
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Pharmacogenetic Assessment System 2025-16037	Food and Drug Administration	Final rule	Aug 21, 2025
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Menopause Test System 2025-16036	Food and Drug Administration	Final rule	Aug 21, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Cancer Predisposition Risk Assessment System 2025-16035	Food and Drug Administration	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	Food and Drug Administration	Final rule	Aug 21, 2025
Medical Devices; Radiology Devices; Classification of the Liver Iron Concentration Imaging Companion Diagnostic for Deferasirox 2025-16033	Food and Drug Administration	Final rule	Aug 21, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Postnatal Chromosomal Copy Number Variation Detection System 2025-16032	Food and Drug Administration	Final rule	Aug 21, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Anti-Phospholipase A2 Receptor Immunological Test System 2025-16031	Food and Drug Administration	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	Food and Drug Administration	Final rule	Aug 21, 2025
Reproductive Health Services 2025-14687 · significant	Veterans Affairs Department	Proposed rule	Aug 4, 2025
Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program 2025-13271 · significant	Centers for Medicare & Medicaid Services	Proposed rule	Jul 16, 2025
Listing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue 2025-13175	Food and Drug Administration	Final rule	Jul 15, 2025
Medicare and Medicaid Programs; Calendar Year 2026 Home Health Prospective Payment System (HH PPS) Rate Update; Requirements for the HH Quality Reporting Program and the HH Value-Based Purchasing Expanded Model; Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program Updates; DMEPOS Accreditation Requirements; Provider Enrollment; and Other Medicare and Medicaid Policies 2025-12347 · significant	Centers for Medicare & Medicaid Services	Proposed rule	Jul 2, 2025
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Muscular Dystrophy Newborn Screening Test 2025-11796	Food and Drug Administration	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	Food and Drug Administration	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	Food and Drug Administration	Final rule	Jun 26, 2025
Medical Devices; Radiology Devices; Classification of the Cream for X-Ray Attenuation 2025-11791	Food and Drug Administration	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	Food and Drug Administration	Final rule	Jun 26, 2025
Medical Devices; Exemptions From Premarket Notification: Class II Devices; Clinical Electronic Thermometers 2025-11207	Food and Drug Administration	Final rule	Jun 18, 2025
Medical Devices; Radiology Devices; Classification of the Radiological Computer-Assisted Detection and Diagnosis Software 2025-10789	Food and Drug Administration	Final rule	Jun 13, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Clinical Mass Spectrometry Microorganism Identification and Differentiation System 2025-10788	Food and Drug Administration	Final rule	Jun 13, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Cellular Analysis System for Multiplexed Antimicrobial Susceptibility Testing 2025-10787	Food and Drug Administration	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	Food and Drug Administration	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	Food and Drug Administration	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	Food and Drug Administration	Final rule	Jun 2, 2025
Medical Devices; Radiology Devices; Classification of the Radiological Acquisition and/or Optimization Guidance System 2025-09837	Food and Drug Administration	Final rule	Jun 2, 2025
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Anti-Mullerian Hormone Test System 2025-09776	Food and Drug Administration	Final rule	May 30, 2025
Listing of Color Additives; Myoglobin; Confirmation of Effective Date 2025-09680	Food and Drug Administration	Final rule	May 29, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Inherited Nucleotide Repeat Disorder Deoxyribonucleic Acid Test 2025-09641	Food and Drug Administration	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	Food and Drug Administration	Final rule	May 29, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Zika Virus Serological Reagents 2025-09639	Food and Drug Administration	Final rule	May 29, 2025
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Plazomicin Test System 2025-09638	Food and Drug Administration	Final rule	May 29, 2025
Medicare and Medicaid Programs; CY 2025 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program; and Medicare Overpayments; and Appeal Rights for Certain Changes in Patient Status; Corrections and Correcting Amendment 2025-08676	Centers for Medicare & Medicaid Services	Final rule	May 16, 2025
Listing of Color Additives Exempt From Certification; Galdieria Extract Blue 2025-08250	Food and Drug Administration	Final rule	May 12, 2025
Listing of Color Additives Exempt From Certification; Calcium Phosphate 2025-08249	Food and Drug Administration	Final rule	May 12, 2025
Listing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract 2025-08248	Food and Drug Administration	Final rule	May 12, 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	Food and Drug Administration	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	Food and Drug Administration	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	Food and Drug Administration	Final rule	May 9, 2025
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Voriconazole Test System 2025-08148	Food and Drug Administration	Final rule	May 9, 2025
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Breast Milk Macronutrients Test System 2025-08147	Food and Drug Administration	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	Food and Drug Administration	Final rule	May 9, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Microbial Nucleic Acid Storage and Stabilization Device 2025-08145	Food and Drug Administration	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	Food and Drug Administration	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	Food and Drug Administration	Final rule	May 9, 2025
Listing of Color Additives Exempt From Certification; Myoglobin 2025-01239	Food and Drug Administration	Final rule	Jan 17, 2025
Medicare Program: Appeal Rights for Certain Changes in Patient Status and Changes to the Medicare Claims and Medicare Prescription Drug Coverage Determination Appeals Procedures; Correcting Amendment 2024-31146	Centers for Medicare & Medicaid Services	Final rule	Dec 30, 2024
Clinical Trials Registration and Results Information Submission 2024-28475	Health and Human Services Department	Final rule	Dec 9, 2024
Medicare and Medicaid Programs; CY 2025 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program; and Medicare Overpayments 2024-25382 · significant	Centers for Medicare & Medicaid Services	Final rule	Dec 9, 2024
Medicare Program: Appeal Rights for Certain Changes in Patient Status 2024-23195 · significant	Centers for Medicare & Medicaid Services	Final rule	Oct 15, 2024
Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices 2024-21932	Food and Drug Administration	Proposed rule	Sep 25, 2024
Microbiology Devices; Reclassification of Cytomegalovirus Deoxyribonucleic Acid Quantitative Assay Devices Intended for Transplant Patient Management 2024-21616	Food and Drug Administration	Final rule	Sep 23, 2024
Medical Devices; Immunology and Microbiology Devices; Classification of the Quantitative Viral Nucleic Acid Test for Transplant Patient Management 2024-21086	Food and Drug Administration	Final rule	Sep 17, 2024
Medical Devices; Therapeutic Devices; Classification of the Pediatric Continuous Renal Replacement Therapy System 2024-20999	Food and Drug Administration	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	Food and Drug Administration	Final rule	Sep 16, 2024
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Clozapine Test System 2024-20895	Food and Drug Administration	Final rule	Sep 16, 2024
Medical Devices; Immunology and Microbiology Devices; Classification of the Whole Exome Sequencing Constituent Device 2024-20550	Food and Drug Administration	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	Food and Drug Administration	Final rule	Sep 9, 2024
Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Pancreatic Debridement Device 2024-20248	Food and Drug Administration	Final rule	Sep 9, 2024
Medical Devices; Gastroenterology-Urology Devices; Classification of the Hemodialyzer With Expanded Solute Removal Profile 2024-20081	Food and Drug Administration	Final rule	Sep 6, 2024
Medical Devices; Ophthalmic Devices; Classification of the Hydrophilic Re-Coating Solution 2024-19882	Food and Drug Administration	Final rule	Sep 5, 2024
Medical Devices; Dental Devices; Classification of the Radiofrequency Toothbrush 2024-19868	Food and Drug Administration	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	Food and Drug Administration	Final rule	Sep 5, 2024
Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Open Loop Fluid Therapy Recommender 2024-19736	Food and Drug Administration	Final rule	Sep 5, 2024
Medical Devices; Orthopedic Devices; Classification of the Intervertebral Body Graft Containment Device 2024-19726	Food and Drug Administration	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	Food and Drug Administration	Final rule	Sep 3, 2024
Medical Devices; Physical Medicine Devices; Classification of the External Compression Device for Internal Jugular Vein Compression 2024-19722	Food and Drug Administration	Final rule	Sep 3, 2024
Medical Devices; Neurological Devices; Classification of the Digital Therapy Device for Attention Deficit Hyperactivity Disorder 2024-19720	Food and Drug Administration	Final rule	Sep 3, 2024
Medicare and Medicaid Programs and the Children's Health Insurance Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2025 Rates; Quality Programs Requirements; and Other Policy Changes 2024-17021	Centers for Medicare & Medicaid Services	Final rule	Aug 28, 2024
Medical Devices; General Hospital and Personal Use Devices; Classification of the Intravenous Catheter Force-Activated Separation Device 2024-18267	Food and Drug Administration	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	Food and Drug Administration	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	Food and Drug Administration	Final rule	Aug 16, 2024
Medicare and Medicaid Programs; CY 2025 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program; and Medicare Overpayments 2024-14828	Centers for Medicare & Medicaid Services	Proposed rule	Jul 31, 2024
Center for Innovation for Care and Payment Update 2024-16601	Veterans Affairs Department	Final rule	Jul 29, 2024
Ophthalmic Practice Rules (Eyeglass Rule) 2024-15620	Federal Trade Commission	Final rule	Jul 26, 2024
Standards for Accessible Medical Diagnostic Equipment 2024-16266	Architectural and Transportation Barriers Compliance Board	Final rule	Jul 25, 2024
Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases 2024-13190	Food and Drug Administration	Final rule	Jun 18, 2024
Adaptive Equipment Allowance 2024-13116	Veterans Affairs Department	Final rule	Jun 17, 2024
Ophthalmic Devices; Reclassification of Ultrasound Cyclodestructive Device 2024-10895	Food and Drug Administration	Final rule	May 20, 2024
Medical Devices; Laboratory Developed Tests 2024-08935	Food and Drug Administration	Final rule	May 6, 2024
Medicare and Medicaid Programs and the Children's Health Insurance Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2025 Rates; Quality Programs Requirements; and Other Policy Changes 2024-07567	Centers for Medicare & Medicaid Services	Proposed rule	May 2, 2024
CHAMPVA Coverage of Audio-Only Telehealth, Mental Health Services, and Cost Sharing for Certain Contraceptive Services and Contraceptive Products Approved, Cleared, or Granted by FDA 2024-09072 · significant	Veterans Affairs Department	Final rule	Apr 30, 2024
Banned Devices; Proposal To Ban Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior 2024-06037	Food and Drug Administration	Proposed rule	Mar 26, 2024
Medical Devices; Technical Amendments 2024-05473	Food and Drug Administration	Final rule	Mar 15, 2024
Reproductive Health Services 2024-04275 · significant	Veterans Affairs Department	Final rule	Mar 4, 2024
North Korea Sanctions Regulations 2024-03255	Foreign Assets Control Office	Final rule	Feb 16, 2024
Beneficiary Travel and Special Mode Transportation Under 38 U.S.C. 111 Within the United States 2024-03127 · significant	Veterans Affairs Department	Final rule	Feb 15, 2024
Medical Devices; Quality System Regulation Amendments 2024-01709	Food and Drug Administration	Final rule	Feb 2, 2024
Listing of Color Additives Exempt From Certification; Jagua (Genipin-Glycine) Blue; Confirmation of Effective Date 2024-01106	Food and Drug Administration	Final rule	Jan 23, 2024

Federal rules on medical devices: 198 since January 2024

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