Ozell Sanders
Lead Reviewer, Division of Neuromodulation and Physical Medicine Devices at FDA
- Role
- Lead Reviewer Office of Neurological and Physical Medicine Devices at FDA
- Location
- Baltimore, MD, US
- LinkedIn followers
- 500 followers
Experience
Lead Reviewer Office of Neurological and Physical Medicine Devices
Sep 2019 — Present · Silver Spring, MD, US
As a lead reviewer, I review Premarket (510(k)) notifications, Investigational Device Exemptions (IDE) applications, Premarket Approval (PMA) applications, Pre-investigational submissions (Q-Submissions) to determine substantial equivalence compared to predicate devices, safety and effectiveness, and significant/non-significant risks of study protocols. I review devices ranging from therapeutic and functional devices including spinal cord stimulators, wheelchairs, powered exoskeleton devices, prosthetic devices, powered muscle stimulator/transcutaneous electrical nerve stimulator devices, and other physical medicine devices
Education
University of Maryland Baltimore County
Bachelor of Science (B.S.)
2004 — 2009
University of Maryland Baltimore
Doctor of Philosophy (Ph.D.)
2011 — 2018
University of Maryland Baltimore County
Master of Science (M.S.)
2009 — 2011
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