FDA Brief: Week of Feb 29, 2016
- 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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