Sugato De, M.S.

Sugato De, M.S.

Sugato De, M.S.

Principal Consultant

Sugato is a seasoned, accomplished engineer with wide-ranging experience in the development and regulation of medical devices and in the creation and implementation of scientific and regulatory policy. Sugato has greater than 11 years of experience in the Center for Devices and Radiological Health (CDRH) at the FDA and has specialized expertise in the development of performance assessment methodologies for drug-delivery systems and in the development of clinical trials to establish the safety and efficacy of medical devices. Sugato uses his extensive scientific, technical, device development and regulatory experience to assist clients in the development of nonclinical and clinical development plans and regulatory strategies with FDA to achieve their company objectives.

Work Experience

Prior to joining Parexel, Sugato held positions at CDRH as a Senior Policy Advisor in the Office of the Center Director (OCD), and as Branch Chief, Compliance Officer and a Biomedical Engineer. During his career, he developed extensive experience in the engineering and clinical assessment of medical devices, particularly drug-delivery systems, ventilators, anesthesia gas machines, human factors, and software-driven applications. As a Branch Chief and Biomedical Engineer, he supervised review teams and provided technical and scientific expertise during the review of the broad spectrum of CDRH submissions, including 510(k)s, PMAs, IDEs, de novo applications and Pre-Submissions. He also served as CDRH’s lead representative on the review of over 50 combination product reviews submitted via INDs, NDAs and BLAs and has comprehensive knowledge of regulatory strategies for the approval of these products. In 3 years with OCD in CDRH, he served as a senior policy advisor to the Center Director, supervising numerous policy initiatives.

Education

Sugato has an M.S., in Biomedical Engineering from Johns Hopkins University and a B.S. in Biomedical Engineering and Electrical Engineering from Rensselaer Polytechnic Institute.

We are always available for a conversation.

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