May 2016 – Drug and Device Digest

FDA NOTES: MDUFA IV Discussions, CDRH Early Feasibility Studies

FDA BRIEF: Week of May 23, 2016


Stakeholders present : Alliance for Aging Research, Duke University, National Center for Health Research, Alliance for Aging Research, National Coalition for Cancer Survivorship, National Health Council , American College of Cardiology, American Association of Neurological Surgeons, FasterCures, JDRF, Women’s Health Research, Pew Charitable Trusts, National Organization for Rare Disorders, Research!America, National Alliance on Mental Illness, Avalere Health

Current status of proposals:

  • Core infrastructure of Quality System critical for establishing consistency and long-term stability
  • Key innovation initiatives: Real World Evidence (RWE) and Digital Health
  • Additional dialogue needed : De Novos and Presubmissions
  • FOCUS TOPIC: Establishing National Evaluation System for Medical Devices and impact on  user fee negotiations
    • Goal to establish collaboration leveraging data from registries, medical claims, electronic health records, and potentially other source
    • RWE leveraged for premarket and postmarket regulatory decisions
    • Additional time and cost develop necessary infrastructure and coordinating center
    • Funding sources: Congressional budget, private-sector, or both
    • User fee investment for better quality registries for premarket regulatory decision-making, nest clinical trials in registries to reduce cost of evidence generation




  • CDRH Learn Module updated  Early Feasibility Studies for Medical Devices to include a new section on the Device Evaluation Strategy
  • Describes and justifies the appropriate testing to support initiation of a clinical study
  • Processes for FDA engagement



Scroll to Top