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; Immunology and Microbiology Devices; Classification of the Hematopoietic Cell Enrichment Kit
2026-20725 | Food and Drug Administration | Final rule | Oct 9 |
Low-Value Shipments
2026-20650 | U.S. Customs and Border Protection | Proposed rule | Oct 8 |
Clinical Laboratory Improvement Amendments of 1988 (CLIA); Virtual Access, Gynecologic Cytology Proficiency Testing (PT), Personnel Qualifications, and Other Changes
2026-20613 | Centers for Medicare & Medicaid Services | Proposed rule | Oct 8 |
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 |
Automated Commercial Environment (ACE) Electronic Export Manifest for Rail Cargo
2026-17390 · significant | U.S. Customs and Border Protection | Final rule | Aug 26 |
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; 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 |
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 |
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; Immunology and Microbiology Devices; Classification of the SARS-CoV-2 Serology Test
2026-12902 | Food and Drug Administration | Final rule | Jun 26 |
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; 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; 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 |
Procedures for Transportation Workplace Drug and Alcohol Testing Programs
2026-09290 | Transportation Department | Final rule | May 11 |
Modification of Certain Terminology in Title 21
2026-08826 | Food and Drug Administration | Proposed 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 |
Eliminating Regulations Establishing Fellowships in Laboratory Standardization and Testing for Foreign Citizens
2026-08018 | National Institute of Standards and Technology | Final rule | Apr 24 |
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 |
Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability Standards and Prior Authorization for Drugs for Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children's Health Insurance Program (CHIP) Agencies and CHIP Managed Care Entities, and Issuers of Qualified Health Plans on the Federally-Facilitated Exchanges
2026-07205 · significant | 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 |
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 |
Electronic Bond Transmission
2026-02961 · significant | U.S. Customs and Border Protection | Proposed rule | Feb 13 |
Electronic Export Manifest for Vessel Cargo
2026-02662 · significant | U.S. Customs and Border Protection | Proposed rule | Feb 10 |
Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions To Unleash Prosperity
2025-23896 · significant | Health and Human Services Department | Proposed rule | Dec 29, 2025 |
Medical Devices; Quality Management System Regulation Technical Amendments
2025-21955 | Food and Drug Administration | Final rule | Dec 4, 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 Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Overall Hospital Quality Star Rating; Hospital Price Transparency; and Notice of Closure of a Teaching Hospital and Opportunity To Apply for Available Slots
2025-20907 · significant | Centers for Medicare & Medicaid Services | Final 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 |
Procedures for Transportation Workplace Drug and Alcohol Testing Programs
2025-19119 | Transportation Department | Proposed rule | Oct 1, 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 |
Agreement Between the United States of America, the United Mexican States, and Canada (USMCA) Implementing Regulations Related to Textile and Apparel Goods, Automotive Goods, and Other USMCA Provisions; Correcting Amendments
2025-17122 | Treasury Department | Final rule | Sep 8, 2025 |
Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Addition of Fentanyl to the Department of Transportation's Drug-Testing Panel; Harmonization With Certain Items in the HHS Mandatory Guidelines for Urine and Oral Fluid; and Technical Amendments
2025-16720 | Transportation Department | Proposed rule | Sep 2, 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; 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; 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 |
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) 2026 Rates; Changes to the FY 2025 IPPS Rates Due to Court Decision; Requirements for Quality Programs; and Other Policy Changes; Health Data, Technology, and Interoperability: Electronic Prescribing, Real-Time Prescription Benefit and Electronic Prior Authorization
2025-14681 | Centers for Medicare & Medicaid Services | Final rule | Aug 4, 2025 |
Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Overall Hospital Quality Star Ratings; and Hospital Price Transparency
2025-13360 · significant | Centers for Medicare & Medicaid Services | Proposed rule | Jul 17, 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 |
Publication Method of Lists of States With and Without State Meat or Poultry Inspection Programs
2025-11816 | Food Safety and Inspection Service | 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; 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 |
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; 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; Immunology and Microbiology Devices; Classification of the Zika Virus Serological Reagents
2025-09639 | Food and Drug Administration | Final rule | May 29, 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; 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 |
Agreement Between the United States of America, the United Mexican States, and Canada (USMCA) Implementing Regulations Related to Textile and Apparel Goods, Automotive Goods, and Other USMCA Provisions
2025-00550 | Treasury Department | Final rule | Jan 17, 2025 |
Automated Commercial Environment (ACE) Electronic Export Manifest for Rail Cargo
2024-31331 · significant | U.S. Customs and Border Protection | Proposed rule | Jan 13, 2025 |
Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List
2024-29567 · significant | Animal and Plant Health Inspection Service | Final rule | Dec 17, 2024 |
Health Data, Technology, and Interoperability: Trusted Exchange Framework and Common Agreement (TEFCA)
2024-29163 | Health and Human Services Department | Final rule | Dec 16, 2024 |
Procedures for Transportation Workplace Drug and Alcohol Testing Programs
2024-28561 | Transportation Department | Proposed rule | Dec 9, 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 and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs, Including the Hospital Inpatient Quality Reporting Program; Health and Safety Standards for Obstetrical Services in Hospitals and Critical Access Hospitals; Prior Authorization; Requests for Information; Medicaid and CHIP Continuous Eligibility; Medicaid Clinic Services Four Walls Exceptions; Individuals Currently or Formerly in Custody of Penal Authorities; Revision to Medicare Special Enrollment Period for Formerly Incarcerated Individuals; and All-Inclusive Rate Add-On Payment for High-Cost Drugs Provided by Indian Health Service and Tribal Facilities
2024-25521 | Centers for Medicare & Medicaid Services | Final rule | Nov 27, 2024 |
Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, Conditions for Coverage for End-Stage Renal Disease Facilities, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model
2024-25486 | Centers for Medicare & Medicaid Services | Final rule | Nov 12, 2024 |
Procedures for Transportation Workplace Drug and Alcohol Testing Programs
2024-25403 | Transportation Department | Final rule | Nov 5, 2024 |
Electronic Signatures, Forms and Storage for Drug and Alcohol Testing Records
2024-23427 | Pipeline and Hazardous Materials Safety Administration | Proposed 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 |
Marine Equipment on Board Vessels and Offshore Units or Facilities
2024-20380 | Coast Guard | Final rule | Sep 18, 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; 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; 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; 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 |
Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability
2024-14975 · significant | Health and Human Services Department | Proposed rule | Aug 5, 2024 |
Procedures for Transportation Workplace Drug and Alcohol Testing Programs; Withdrawal of Direct Final Rule
2024-16765 | Transportation Department | Final rule | Aug 1, 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 |
Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs, Including the Hospital Inpatient Quality Reporting Program; Health and Safety Standards for Obstetrical Services in Hospitals and Critical Access Hospitals; Prior Authorization; Requests for Information; Medicaid and CHIP Continuous Eligibility; Medicaid Clinic Services Four Walls Exceptions; Individuals Currently or Formerly in Custody of Penal Authorities; Revision to Medicare Special Enrollment Period for Formerly Incarcerated Individuals; and All-Inclusive Rate Add-On Payment for High-Cost Drugs Provided by Indian Health Service and Tribal Facilities
2024-15087 | Centers for Medicare & Medicaid Services | Proposed rule | Jul 22, 2024 |
Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, Conditions for Coverage for End-Stage Renal Disease Facilities, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model
2024-14359 | Centers for Medicare & Medicaid Services | Proposed rule | Jul 5, 2024 |
Enforcement of Copyrights and the Digital Millennium Copyright Act
2024-13329 · significant | Treasury Department | Final rule | Jun 24, 2024 |
Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Technical Amendments
2024-12749 | Transportation Department | Final rule | Jun 21, 2024 |
Procedures for Transportation Workplace Drug and Alcohol Testing Programs
2024-12748 | Transportation Department | Proposed rule | Jun 21, 2024 |
Procedures for Transportation Workplace Drug and Alcohol Testing Programs
2024-12747 | Transportation Department | Final rule | Jun 21, 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 |
Medicare Program; Medicare Prescription Drug Benefit Program; Health Information Technology Standards and Implementation Specifications
2024-12842 | Centers for Medicare & Medicaid Services | Final rule | Jun 17, 2024 |
Approval Tests and Standards for Combination Unit Respirators
2024-03849 | Health and Human Services Department | Proposed rule | Mar 15, 2024 |
Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List
2024-01501 · significant | Animal and Plant Health Inspection Service | Proposed rule | Jan 30, 2024 |
Safeguarding the Rights of Conscience as Protected by Federal Statutes
2024-00091 | Health and Human Services Department | Final rule | Jan 11, 2024 |
Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing
2023-28857 | Health and Human Services Department | Final rule | Jan 9, 2024 |