Deputy Director, Office of Clinical Evidence and Analysis
FDA CDRH
Felipe Aguel is a Deputy Director of the Office of Clinical Evidence and Analysis (OCEA) at the Center for Devices and Radiological Health. OCEA
supports the Center by providing policy and technical support across a range of subject areas including IDE policy, expedited programs, biostatistics,
bioresearch monitoring, MedSun, real world evidence, and epidemiology. In this role he has worked closely with the National Evaluation System for Health Technologies (NEST) to shape its role in the medical device real-world evidence ecosystem, as well as in the execution of NEST projects whose goal is to support pre-market regulatory decisions. Felipe is a biomedical engineer, and has held several positions in CDRH, including lab scientist in the Office of Science and Engineering Labs, as well as reviewer and leadership positions at CDRH’s cardiology and neurology review divisions. He also held regulatory leadership positions in the medical device industry before returning to CDRH in his current role.
Health Authority Forum: CDRH - FDA's Center for Devices and Radiological Health
Wednesday, September 18, 2024
2:15 PM – 3:15 PM PDT