The United States regulates medical products primarily through the Food and Drug Administration, which oversees drug approvals, device clearances and approvals, biologics, and digital health. FDA guidance on Software as a Medical Device, clinical decision support, and artificial intelligence shapes global practice, and federal agencies also set rules on reimbursement and health data. This page collects the US regulatory updates HealthSignal tracks across medicines, devices, and digital health, from official public sources only.
CMS proposes a faster pathway for manufacturers to obtain Medicare coverage of new medical devices.
US CMS Newsroom · United StatesFDA announces final ICH guidance on harmonized digital clinical trial protocol standards, templates, and technical specifications for international regulatory exchange.
US Federal Register - FDA Guidance Notices · United StatesFDA guidance establishes a risk-based framework for human factors information required in device marketing submissions to CDRH.
US Federal Register - FDA Guidance Notices · United StatesFDA announces medical device user fee rates and payment procedures for FY 2027 (October 1, 2026 – September 30, 2027) under MDUFA V.
US Federal Register - FDA Notices · United StatesDEA and HHS extend telemedicine flexibilities for controlled-medication prescribing through December 31, 2026.
US Federal Register - DEA Telehealth Rules · United StatesFDA CDER requests feedback on developing a cross-sector collaborative platform to advance quantitative medicine approaches in drug development and regulatory science.
US Federal Register - FDA Notices · United StatesFDA guidance describing its intent to exempt certain unclassified medical devices from premarket notification requirements.
US Federal Register - FDA Guidance Notices · United StatesProposed requirements for electronic prior authorization for drugs and extended interoperability standards across Medicare Advantage, Medicaid, CHIP, and QHP issuers.
US Federal Register - CMS Rules · United StatesDEA establishes Special Registration framework for telemedicine practitioners to prescribe controlled substances without in-person evaluation, with heightened recordkeeping and reporting requirements.
US Federal Register - DEA Telehealth Rules · United StatesDEA extends telemedicine flexibilities for controlled-medication prescribing through December 31, 2025.
US Federal Register - DEA Telehealth Rules · United StatesCMS revises IPPS and LTCH payment rates for FY 2027, updates quality program requirements, and ONC adopts updated health IT standards.
US Federal Register - CMS Rules · United StatesCMS and CDC seek public input on updating CLIA regulations covering breath testing, laboratory processes, emergency preparedness, biosafety, biosecurity, and cybersecurity.
US Federal Register - CMS Rules · United StatesFDA announces draft guidance answering common questions on Forms 3542a and 3542 for applicants submitting to the Agency.
US Federal Register - FDA Guidance Notices · United StatesFDA finalizes ICH M15 guidance on model-informed drug development planning, evaluation, documentation, and regulatory submission.
US Federal Register - FDA Guidance Notices · United StatesRevised draft guidance on manufacturer communications of health care economic information about approved drugs and devices to payors and formulary committees.
US Federal Register - FDA Guidance Notices · United StatesFDA draft guidance on developing container closure systems and device constituent parts for biosimilar and interchangeable biosimilar products.
US Federal Register - FDA Guidance Notices · United StatesDEA finalizes rules preventing illegal distribution of controlled substances via internet, including telehealth prescribing restrictions and identity verification requirements.
US Federal Register - DEA Telehealth Rules · United StatesDEA issues interim rule amending regulations to implement the Ryan Haight Act's provisions preventing illegal distribution of controlled substances via the Internet.
US Federal Register - DEA Telehealth Rules · United StatesCMS proposes updates to physician fee schedule, Part B payment policies, Medicare Shared Savings Program, Quality Payment Program, and Promoting Interoperability Program for calendar year 2027.
US Federal Register - CMS Rules · United StatesDEA and HHS postponed the effective dates of final rules expanding buprenorphine telemedicine treatment and VA continuity-of-care telemedicine from March 21 to a later date pending further review.
US Federal Register - DEA Telehealth Rules · United StatesDEA and HHS delayed the effective date of two final rules on buprenorphine telemedicine and VA continuity of care from February 18 to March 21, 2025.
US Federal Register - DEA Telehealth Rules · United StatesDEA and HHS amend regulations to permit audio-only telemedicine prescribing of schedule III-V controlled substances for opioid use disorder after PDMP review.
US Federal Register - DEA Telehealth Rules · United StatesDEA extends temporary exceptions allowing telemedicine prescribing of controlled medications without prior in-person evaluation beyond November 11, 2023.
US Federal Register - DEA Telehealth Rules · United StatesDEA extends temporary exceptions to controlled-medication prescribing rules to permit telemedicine without prior in-person evaluation pending final rulemaking.
US Federal Register - DEA Telehealth Rules · United StatesDEA proposes rule permitting telehealth prescribing of controlled medications without prior in-person evaluation in limited circumstances.
US Federal Register - DEA Telehealth Rules · United StatesCMS updates Medicare payment policies and rates for hospital inpatient and long-term care hospital services for fiscal year 2027.
US CMS Newsroom · United StatesFDA announces biosimilar user fee rates for FY 2027 under the Biosimilar User Fee Amendments of 2022.
US Federal Register - FDA Notices · United StatesFinal rule implements SUPPORT Act amendments to expand practitioner qualifications and pharmacy delivery options for opioid-use-disorder medication-assisted treatment via telehealth.
US Federal Register - DEA Telehealth Rules · United StatesVA practitioners may prescribe controlled substances via telemedicine to VA patients without prior in-person evaluation if another VA practitioner previously evaluated the patient.
US Federal Register - DEA Telehealth Rules · United StatesDEA amends regulations to expand authorization for practitioners to prescribe schedule III-V narcotic drugs for maintenance or withdrawal management via telemedicine, including audio-only encounters.
US Federal Register - DEA Telehealth Rules · United StatesDEA permits mobile components of registered narcotic treatment programs to dispense controlled substances at remote locations without separate registration.
US Federal Register - DEA Telehealth Rules · United StatesFDA finalizes guidance on clinical trial design and conduct for psychedelic drug development in psychiatric and substance use disorder treatment.
US Federal Register - FDA Guidance Notices · United StatesFinal rule updates IRF prospective payment rates for FY 2027, completes rural adjustment phaseout, and establishes therapy and team-meeting timing requirements.
US Federal Register - CMS Rules · United StatesUpdates hospice wage index, payment rates, aggregate cap, and quality reporting requirements for fiscal year 2027.
US Federal Register - CMS Rules · United StatesCMS updates IPF prospective payment rates, wage index, outlier thresholds, and implements standardized patient assessment for FY 2027.
US Federal Register - CMS Rules · United StatesFinal rule updates SNF prospective payment rates, quality reporting requirements, and value-based purchasing program for FY 2027.
US Federal Register - CMS Rules · United StatesCMS issued a final rule updating Medicare payment policies and rates for inpatient rehabilitation facilities for fiscal year 2027.
US CMS Newsroom · United StatesCMS updates Medicare hospice payment rates, wage index, and quality reporting requirements for fiscal year 2027.
US CMS Newsroom · United StatesCMS updates HCPCS codes on the Master List and the Required Face-to-Face Encounter and Written Order Prior to Delivery and Prior Authorization Lists.
US Federal Register - CMS Rules · United StatesFDA announces prescription drug user fee rates for FY 2027 under PDUFA VII.
US Federal Register - FDA Notices · United StatesCMS issued a final rule updating Medicare payment policies and rates for inpatient psychiatric facilities for fiscal year 2027.
US CMS Newsroom · United StatesCMS issued final rule updating Medicare payment policies and rates for skilled nursing facilities for fiscal year 2027.
US CMS Newsroom · United StatesProposed rule revising indirect hold harmless thresholds for health care-related taxes, effective October 1, 2026 and 2027, implementing the Working Families Tax Cut legislation.
US Federal Register - CMS Rules · United StatesCMS issued draft guidance on processes and requirements for manufacturers to implement maximum fair prices in the 2028 Medicare drug price negotiation program.
US CMS Newsroom · United StatesFDA classifies diabetes digital behavioral therapeutic devices into class II with special controls to ensure safety and effectiveness.
US Federal Register - FDA Rules · United StatesFDA revises draft guidance on design, analysis and regulatory submission of master protocol trials for drug and biological product development.
US Federal Register - FDA Guidance Notices · United StatesFDA announces FY 2027 fee rates for domestic and foreign facility reinspections, recall compliance failures, and importer reinspections under FSMA.
US Federal Register - FDA Guidance Notices · United StatesFDA announces FY 2027 annual and initial/renewal fee rates for accreditation bodies and certification bodies in the FSMA third-party certification program.
US Federal Register - FDA Notices · United StatesFDA announces user fee rates and payment procedures for FY 2027 generic new animal drug applications under AGDUFA IV.
US Federal Register - FDA Notices · United StatesFDA announces fiscal year 2027 fee rates for generic drug applications, facilities, and applicant programs under GDUFA III.
US Federal Register - FDA Notices · United States