Fernando Aguel

Fernando Aguel

Vice President, Heart Failure & Circulatory Support Regulatory Affairs
Background

Mr. Aguel specializes in developing and refining regulatory strategy for Heart Failure and Circulatory Support devices. Including development of regulatory submissions, interacting with the FDA, clinical trial design, and review and analysis of pre-clinical and clinical data. He specializes in devices used to treat heart failure and circulatory support devices, including durable and percutaneous ventricular assist devices (VAD), artificial hearts, intra-aortic balloon pumps, cardio-pulmonary bypass and extra-corporeal membrane oxygenation (ECMO) devices, and other devices to treat heart failure and pulmonary hypertension in addition to CPR devices, heart transplant organ-preservation systems, compressible limb sleeves, auto-transfusion devices, heater-cooler devices and temperature management devices and more.

Education

Mr. Aguel received a B.S and M.S. in BioEngineering, specializing in Biomechanics, from the University of Pittsburgh.

Experience

Mr. Aguel was the Assistant Division Director for the Circulatory Support Devices Team in the office of Cardiovascular Devices at the U.S. Food and Drug Administration for 8 years. Mr. Aguel led a multidisciplinary team of scientific reviewers for all types of submissions including PMAs, IDEs, 510(k)s, Pre-Submissions, Breakthrough Device Designation requests, HDEs, EUAs (during COVID-19 pandemic), DeNovo submissions, 513(g)s and more. In this role, Mr. Aguel oversaw the regulatory review of durable and percutaneous ventricular assist devices (VAD), artificial hearts, intra-aortic balloon pumps, cardio-pulmonary bypass and extra-corporeal membrane oxygenation (ECMO) devices, and other devices to treat heart failure and pulmonary hypertension in addition to CPR devices, heart transplant organ-preservation systems, compressible limb sleeves, auto-transfusion devices, heater-cooler devices and temperature management devices and more. Mr. Aguel also oversaw the device recall classifications, EIR reviews, safety-signal reviews, warning letter responses and decisions on escalation or de-escalation of compliance actions. Mr. Aguel oversaw and participated in many advisory committee panel meetings for premarket submissions, postmarket issues, and for device area reclassifications.

Prior to becoming Assistant Division Director, Mr. Aguel served as a lead reviewer for 7 years in the (then) division of cardiovascular devices. Mr. Aguel’s review areas primarily focused on the heart valve replacement and repair devices and vascular closure and hemostasis devices. As a reviewer of heart valve replacement and repair devices, Mr. Aguel participated in standard development of the first transcatheter heart valve standard and updates to OPCs used for surgical heart valve trials. Mr. Aguel led a team review of and presented at an advisory committee panel meeting for a novel transcatheter mitral valve repair device.

Mr. Aguel represented the FDA at many conferences and scientific meetings to present regulatory approaches and challenges for multiple device and disease or conditions states, including presentations on regulatory approaches and challenges related to heart valve placement and repair devices and in efforts to develop better data generation in the area of cardiogenic shock. Mr. Aguel is also well versed in studies related to exception from informed consent requirements for emergency research (21 CFR 50.24).

Prior to joining the U.S. FDA, Mr. Aguel spent 1 year working at the U.S. Patent and Trademark Office as a patent examiner for electrical stimulation devices.

Overview

Mr. Aguel has more than 16 years of regulatory affairs experience. He specializes in developing and refining regulatory strategies for Heart Failure and Circulatory Support devices. Including development of regulatory submissions, interacting with the FDA, clinical trial design, and review and analysis of pre-clinical and clinical data.

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