Combination Product Policy Analyst at theFDA
Lead Reviewer for the Neurostimulaton Devices Branch of the Division of Neurological and Physical Medicine Devices
within the Office of Device Evaluation. Review pre-marketing submissions for a variety of device specialities and clinical presentations related to neurology. Assemble teams of expert consultants across the agency to assist in reviews as necessary. Provide guidance to and promote interaction with industry, academic, and government sponsors.
Division Representative for the Early Feasibility Study program. The EFS program is a strategic priority for the Center of Devices and Radiological Health. These studies are focused on promoting innovation of novel medical device technology in the United States and thereby enabling US patients to access these technologies first in the world. As a representative for DNPMD, I interact with sponsors submitting within all three branches of the division from very early stage through to IDE decision. I also provide guidance and training to the other reviewers in my division, and act as a liaison between my division and the EFS program leads.