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
    • FALSE CLAIMS ACT—N.D. Ind.: Court prescribes trial for hospital facing FCA allegations in connection with 340B diversion, retaliation
    • CONDITIONS OF PARTICIPATION—DAB DECISIONS: Facility locked, unstaffed, during posted hours deemed not ‘operational’
      • You have 1 more complimentary views available this month. Log in if you are already a customer
    • CONTROLLED SUBSTANCES—FINAL RULES: Adjustment to the 2026 Aggregate Production Quota for d,lAmphetamine, d-Amphetamine (for Sale), Hydromorphone and Methylphenidate (for Sale) Pursuant to 21 U.S.C. 826(h)
      • You have 1 more complimentary views available this month. Log in if you are already a customer
    • COVERAGE—GAO REPORTS: Medicare, Medicaid beneficiaries generally had opioid overdose reversal medication coverage
      • You have 1 more complimentary views available this month. Log in if you are already a customer
    • DRUGS AND BIOLOGICS—FDA GUIDANCE NOTICES: Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency; Guidance for Industry and Food and Drug Administration Staff; Availability
      • You have 1 more complimentary views available this month. Log in if you are already a customer
    • EXPERT INSIGHTS—DOJ Fraud Division launches Whistleblower Rewards Program offering fast-track payments for fraud tips
      • You have 1 more complimentary views available this month. Log in if you are already a customer
    • MEDICARE PART C / MEDICARE ADVANTAGE—E.D. Pa.: Federal Arbitration Act equitable-relief carve-out excludes challenges to Medicare Advantage reimbursement policy
      • You have 1 more complimentary views available this month. Log in if you are already a customer
    • QUALITY OF CARE—DAB DECISIONS: Medicare accident-hazard rules require pureed meals free of chunks and support immediate-jeopardy penalties
      • You have 1 more complimentary views available this month. Log in if you are already a customer
  • Articles
    • Articles
  • Law Firms
    • Law Firms
  • Organizations
    • Organizations

    Health Law Daily Wrap Up, DRUGS AND BIOLOGICS—FDA GUIDANCE NOTICES: Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency; Guidance for Industry and Food and Drug Administration Staff; Availability, (Nov 12, 2026)

    By WK Editorial Staff

    The FDA is announcing the availability of a final guidance titled "Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency.”

    The guidance describes general recommendations for the validat ...

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

    • Manage Cookie Preferences
    • Privacy Statement
    • Terms of Use