Balancing Pre and Post-Market Data Requirements: Different Scenarios - Dorothy B. Abel, BSBME

↳ This is a section part of Moment: CRT 2015 Technology & Innovation - Session III: What Are the Challenges and Potential Solutions to Meeting Clinical Data Requirements for Premarket Approval (PMA), Post-Market Surveillance and Reimbursement?

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Summary

Balancing Pre and Post-Market Data Requirements: Different Scenarios presented by Dorothy B. Abel, BSBME at CRT 2015

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Target Audience

Interventional Cardiologists
Interventional Fellows
Physicians with an interest in Cardiovascular Innovations

Session Name: Session III: What Are the Challenges and Potential Solutions to Meeting Clinical Data Requirements for Premarket Approval (PMA), Post-Market Surveillance and Reimbursement?

Track: Technology & Innovation

Learning Objectives

Updates in the latest Cardiovascular Innovations

Other Components in this Moment

Overview

Too Costly, Too Slow: The Current PMA Requirements - Keith D. Dawkins, MD

Post-Market Studies: Large Investment, Little Return - Neal E. Fearnot, PhD

Alternatives to Randomized Premarket Studies - Laura Mauri, MD

Balancing Pre and Post-Market Data Requirements: Different Scenarios - Dorothy B. Abel, BSBME

Use of Quality Initiative Registries to Meet Regulatory and Reimbursement Requirements - William S. Weintraub, MD

CMS Participation: Will There Be a Problem with Reimbursement If Less Data Is Available Premarket? - Tamara Syrek Jensen, JD

How Difficult and Expensive Is Coverage with Evidence Development? - Perry Bridger

Problems Will Arise: Is the US Public Ready to Accept Change? - Aaron V. Kaplan, MD