FDA Position and Initiatives

3:15 PM - 4:45 PMWed

Speakers

Pras Pathmanathan

Research Scientist & Lead, OSEL Credibility fo Computational Models Regulatory Science Program

CDRH, FDA

Finn Donaldson

Acting Assistant Director, Peripheral Interventional Devices Team

OPEQ, CDRH, FDA

Andrew Baumann, Ph.D.

Mechanical Engineer, Division of Applied Mechanics

OSEL, CDRH, FDA

Brent Craven

Research Scientist, Division of Applied Mechanics

OSEL, CDRH, FDA

Andreu Badal

Physicist, Division of Imaging, Diagnostics & Software Reliability

OSEL, CDRH, FDA

• Introduction to modeling and simulation at CDRH • Computational modeling in cardiovascular implant durability assessments: an FDA perspective • Computational modeling in orthopedic regulatory submissions • A mock submission to initiate a medical device clinical trial using modeling and simulation • In silico imaging clinical trials for regulatory evaluation of mammography devices