Registry-based Preand Post-market IDE Studies: The FDA View - John Laschinger, MD

↳ This is a section part of Moment: CRT 2016 Technology & Innovation - Registry-based Trials and Device Benefit/Risk: Supporting Regulatory Decisions and Best Practice Guidelines

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Summary

Registry-based Preand Post-market IDE Studies: The FDA View presented by John Laschinger, MD at CRT 2016

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Target Audience

  • Interventional Cardiologists
  • Clinical Trial Investigators
  • Interventional Fellows
  • Medical Device Professionals

Session Name: Registry-based Trials and Device Benefit/Risk: Supporting Regulatory Decisions and Best Practice Guidelines

Track: Technology & Innovation

Learning Objectives

  • Updates in the latest Cardiovascular Innovations

Other Components in this Moment

Overview
Registry-based Preand Post-market IDE Studies: The FDA View - John Laschinger, MD
Making Registries Reliable - John Rumsfeld, MD, PhD
Novel Study Design for Expanded Indications: SAFE STEMI for Seniors - David Kong, MD, AM
Valve Case Study: Registry Support of Both IDE and Surveillance Applications - Danica Marinac-Dabic, MD, PhD
The Early Access PMA Program - Owen Faris, PhD
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