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 |
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 |
Nonclinical Testing Terminology
2026-19350 | Food and Drug Administration | Final rule | Sep 22 |
Nonclinical Testing Terminology
2026-19349 | Food and Drug Administration | Proposed rule | Sep 22 |
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2027 and Updates to the IRF Quality Reporting Program
2026-15652 | Centers for Medicare & Medicaid Services | Final rule | Aug 3 |
Reducing Barriers to Medical Use Licensing
2026-15080 | Nuclear Regulatory Commission | Proposed rule | Jul 27 |
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 |
Requirement To Identify All Real Parties in Interest to a Third Party Request for an Ex Parte Reexamination
2026-14793 | Patent and Trademark Office | Proposed rule | Jul 22 |
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 |
Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; and Quality Reporting Programs; Including the Hospital Outpatient Quality Reporting Program and Ambulatory Surgical Center Quality Program; Request for Information on Strengthening the Standardization and Comparability of Hospital Price Transparency (HPT) Data; Prior Authorization; Accrediting Organization (AO) Deeming for Emergency Medical Treatment and Labor Act (EMTALA); and Notices of Closure of Teaching Hospitals and Opportunities To Apply for Available Slots
2026-13656 | Centers for Medicare & Medicaid Services | Proposed rule | Jul 7 |
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 |
Conditions for Additional Information and Fee in Petitions Filed in Patent Applications and Patents Based on Unintentional Delay
2026-12717 | Patent and Trademark Office | Final rule | Jun 24 |
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 |
Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program
2026-12059 | Centers for Medicare & Medicaid Services | Proposed rule | Jun 16 |
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 |
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 |
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 Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2027 and Updates to the IRF Quality Reporting Program
2026-06642 | Centers for Medicare & Medicaid Services | Proposed rule | Apr 6 |
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 |
Required Use by Foreign Applicants and Patent Owners of a Patent Practitioner
2026-05564 | Patent and Trademark Office | Final rule | Mar 20 |
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 |
Revocation of Regulations Regarding the Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and the European Community
2026-03286 | Food and Drug Administration | Final rule | Feb 19 |
Required Use by Foreign Applicants and Patent Owners of a Patent Practitioner
2025-23917 | Patent and Trademark Office | Proposed rule | Dec 29, 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 |
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 |
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 |
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 |
Eliminating Expedited Examination of Design Applications
2025-15497 | Patent and Trademark Office | Final rule | Aug 14, 2025 |
Significant New Use Rules on Certain Chemical Substances (24-1.5e)
2025-14256 | Environmental Protection Agency | Final rule | Jul 29, 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 |
2025 Increase of the Annual Limit on Accepted Requests for Prioritized Examination
2025-12644 | Patent and Trademark Office | Final rule | Jul 8, 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; 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 |
Discontinuation of the Accelerated Examination Program for Utility Applications
2025-10498 | Patent and Trademark Office | Final rule | Jun 10, 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 |
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 |
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 |
Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins
2024-29583 · significant | Health and Human Services Department | Final rule | Dec 17, 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 |
Setting and Adjusting Patent Fees During Fiscal Year 2025
2024-26821 | Patent and Trademark Office | Final rule | Nov 20, 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 |
Revocation of Regulations Regarding the Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community
2024-21559 | Food and Drug Administration | Proposed rule | Sep 20, 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 |
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 |
21st Century Cures Act: Establishment of Disincentives for Health Care Providers That Have Committed Information Blocking
2024-13793 | Centers for Medicare & Medicaid Services | Final rule | Jul 1, 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 |
Terminal Disclaimer Practice To Obviate Nonstatutory Double Patenting
2024-10166 | Patent and Trademark Office | Proposed rule | May 10, 2024 |
Adoption of Updated WIPO Standard ST.26; Revision to Incorporation by Reference
2024-09618 | Patent and Trademark Office | Final rule | May 3, 2024 |
340B Drug Pricing Program; Administrative Dispute Resolution Regulation
2024-08262 · significant | Health and Human Services Department | Final rule | Apr 19, 2024 |
Setting and Adjusting Patent Fees During Fiscal Year 2025
2024-06250 | Patent and Trademark Office | Proposed rule | Apr 3, 2024 |
Signature Requirements Related to Acceptance of Electronic Signatures for Patent Correspondence
2024-06126 | Patent and Trademark Office | Final rule | Mar 22, 2024 |
Biologics License Applications and Master Files
2024-02741 | Food and Drug Administration | Final rule | Feb 12, 2024 |
Medicare and Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Advantage; Medicare and Medicaid Provider and Supplier Enrollment Policies; and Basic Health Program; Corrections
2024-02705 | Centers for Medicare & Medicaid Services | Final rule | Feb 12, 2024 |
Medical Devices; Quality System Regulation Amendments
2024-01709 | Food and Drug Administration | Final rule | Feb 2, 2024 |
Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins
2024-01513 · significant | Health and Human Services Department | Proposed rule | Jan 30, 2024 |