US Clinical Study Challenges, Including IDE Approval (Including Nonclinical Data Requirements) - Aaron V. Kaplan, MD

↳ This is a section part of Moment: CRT 2015 Technology & Innovation - Session II: Pivotal Study Initiation and Conduct

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Summary

US Clinical Study Challenges, Including IDE Approval (Including Nonclinical Data Requirements) presented by Aaron V. Kaplan, MD at CRT 2015

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Target Audience

  • Interventional Cardiologists
  • Interventional Fellows
  • Physicians with an interest in Cardiovascular Innovations 

Session Name: Session II: Pivotal Study Initiation and Conduct

Track: Technology & Innovation

Learning Objectives

  • Updates in the latest Cardiovascular Innovations

Other Components in this Moment

Overview
Reimbursement Policies for Investigational Device Exemptions (IDEs) CMS view - Tamara Syrek Jensen, JD
Reimbursement Policies for Investigational Device Exemptions (IDEs) Industry View - Mitchell Sugarman, MBA
US Clinical Study Challenges, Including IDE Approval (Including Nonclinical Data Requirements) - Aaron V. Kaplan, MD
Clinical Trial Metrics: A Proposal for Improving Medical Device IRB, Contracting and Study Conduct - Chip Hance
FDA Initiatives to Improve the Clinical Study Ecosystem - Owen P. Faris, PhD
Keynote Address: FDACDRH in the Next Decade – A Vision for Change - William H. Maisel, MD
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