FDA Brief: Week of Feb 29, 2016

fda guidances



  • Leapfrog guidance to provide initial recommendations for emerging medical device technologies that address an unmet medical need
  • For Neurological Devices intended to slow, stop, or reverse the effects of neurological disease e.g.  Alzheimer’s disease, Parkinson’s Disease, or Primary  Dystonia – addresses an important unmet need
  • Summarizes critical Clinical Study Considerations:
    • Biological Markers and Clinical Endpoints including Clinical Outcome Assessments
    • Trial Designs including approaches and limitations
    • Investigational Plan overview
    • Safety Assessments
    • Benefit -Risk Framework including knowledge from clinical, nonclinical and patient domains
    • Labeling including Indications for Use and Warnings/Precautions
  • Advises discusion with review Division via Pre-Submission program



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