Go to Wolters Kluwer VitalLaw.comGo to Wolters Kluwer VitalLaw.com
VitalLaw®
  • Find answers to your questions
  • Log in to access your subscriptions
In depth. On point.
In depth. On point.
  • Home
  • Legal Directory
  • Home
  • Legal Directory
In depth. On point.
  • Articles
    • Articles
  • Law Firms
    • Law Firms
  • Organizations
    • Organizations
    • ARTIFICIAL INTELLIGENCE—D. Ky.: Court parses AI-use causes of action from Medicare Act determinations in Humana class action
    • ACUTE INPATIENT HOSPITALS—OIG REPORTS: Hospitals see increase in inpatient Medicare enrollees leaving before discharge
    • ADMINISTRATION OF MEDICARE/MEDICAID PROGRAMS—DAB DECISIONS: Surgical tech’s five-year exclusion for falsifying patient records justified
    • CLINICAL RESEARCH—FINAL RULES: Terminating National Institutes of Health Minority Biomedical Research Support Program and Rescinding the Program’s Related Regulation
    • GENERAL HEALTH CARE NEWS—D.N.M.: Court denies New Mexico OSI’s motion for summary judgment against health-sharing ministry
    • HIPAA—D. Ariz.: Patients failed to explain how HIPAA and Arizona statutes established public policy imposing duty on hospital
    • MEDICAL DEVICES—FINAL RULES: Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Pharmacogenetic Assessment System
    • MEDICAL DEVICES—FINAL RULES: 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
    • QUI TAM (WHISTLEBLOWER SUITS)—E.D. La.: Still-active 2018 whistleblower suit limited to core claims against wound care firm
  • Articles
    • Articles
  • Law Firms
    • Law Firms
  • Organizations
    • Organizations

    Health Law Daily Wrap Up, MEDICAL DEVICES—FINAL RULES: 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, (Aug 27, 2025)

    By WK Editorial Staff

    The FDA has classified the multiplex respiratory panel to detect and identify emerging respiratory pathogen(s) and common respiratory pathogens in human clinical specimens into class II (special controls).

    The special controls that apply to the device ...

    By WK Editorial Staff

    The FDA has classified the multiplex respiratory panel to detect and identify emerging respiratory pathogen(s) and common respiratory pathogens in human clinical specimens into class II (special controls).

    The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the multiplex respiratory panel to detect and identify emerging respiratory pathogen(s) and common respiratory pathogens in human clinical specimens. The FDA is taking this action having determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. The FDA believes this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens. (Final Rule, 90 Fed. Reg. 40709 (August 21, 2025)).

    Dates. This order is effective August 21, 2025. The classification was applicable on November 24, 2017.

    FederalRegisterIssuances: FinalRules MDeviceNews

    © 2026 CCH Incorporated and its affiliates and licensors. All rights reserved.

    • Manage Cookie Preferences
    • Privacy Statement
    • Terms of Use