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
    • ELECTRONIC HEALTH RECORDS—M.D. Tenn.: Case against health system over tracking technologies remanded to state court
    • ADMINISTRATION OF FDC ACT—NOTICES: Issuance of priority review voucher for Atebrioz, rare pediatric disease product
      • You have 1 more complimentary views available this month. Log in if you are already a customer
    • ADMINISTRATION OF MEDICARE/MEDICAID PROGRAMS—DAB DECISIONS: Suspension of DEA COR legal basis for CMS revocation, preclusion listing
      • You have 1 more complimentary views available this month. Log in if you are already a customer
    • DRUGS AND BIOLOGICS—NOTICES: Determination that Pepcid RPD (tFamotidine) orally disintegrating tablets were not withdrawn from sale for reasons of safety, effectiveness
      • You have 1 more complimentary views available this month. Log in if you are already a customer
    • DRUGS AND BIOLOGICS—NOTICES: Individualized human genome editing products draft guidance recommends considerations for BLA submission, postapproval management
      • You have 1 more complimentary views available this month. Log in if you are already a customer
    • FALSE CLAIMS ACT—SETTLEMENT AGREEMENTS: Dialysis Centers agree to pay $2M to settle fraudulent PRF claims from COVID-19 era
      • You have 1 more complimentary views available this month. Log in if you are already a customer
    • HEALTH INFORMATION TECHNOLOGY—FINAL RULES: Final Rule cuts health IT certification requirements and advances FHIR-focused framework
      • You have 1 more complimentary views available this month. Log in if you are already a customer
    • MEDICAL DEVICES—NOTICES: Electronic submission template for investigational device exemption (IDE) applications draft guidance provides recommendations
      • You have 1 more complimentary views available this month. Log in if you are already a customer
    • WHITE HOUSE NEWS—Cyber Pilot Program for Rural Hospitals Launched by White House
      • 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, MEDICAL DEVICES—NOTICES: Electronic submission template for investigational device exemption (IDE) applications draft guidance provides recommendations, (Oct 29, 2026)

    By WK Editorial Staff

    The draft guidance is not final nor is it for implementation at this time.

    The FDA announced the availability of the draft guidance titled “Electronic Submission Template for Investigational Device Exemption (IDE) Applications.” The FDA ...

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

    • Manage Cookie Preferences
    • Privacy Statement
    • Terms of Use