Regulatory Approval – ISCTR | International Society for Cardiovascular Translational Research

Lecture – Marco Cannella, PhD, FDA

Marco Cannella, PhD Team Lead for Cardiac Ablation, Mapping & Imaging Devices, Office of Product Evaluation & Quality, FDA Learning Objectives Learn the regulatory elements for diagnostic devices Understand the device hazard analysis Understand the regulatory implication for clinical claim Learn the elements needed in preparing for the marketing application

Lecture – Bram Zuckerman, MD, FDA

Bram Zuckerman, MD Director, FDA Division of Cardiovascular Devices Learning Objectives Recognize the complexity of device development Learn the device risk classification Learn the critical issues for device approval, pre-clinical, pivotal trial, manufacturing and labeling Understand the important points in the analysis of the pivotal trial Understand the concept of total product life cycle Recognize […]

Topic Category: Regulatory Approval

Lecture – Marco Cannella, PhD, FDA

Lecture – Bram Zuckerman, MD, FDA

Account

Courses

eBooks

Resources