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Changing Regulatory and Reimbursement Scenario for Medical Devices in the US Market
Date:5/21/2013

510k) or PMA, IDE for clinical studies, QS regulation, labeling requirements, and MDR.

- Information on reimbursement coverage in the US for cardiovascular devices, neurostimulation devices, diagnostic imaging devices and endoscopy devices.

- Annualized market revenue data, forecast to 2018, for the transcatheter heart valves market, left ventricular assist devices market and endoscopy devices market.

- Qualitative analysis of key trends in the US regulatory and reimbursement landscape.

 

Reasons to buy

 

- Develop business strategies by understanding the reimbursement trends in the US medical devices market.

- Design and enhance your product development, marketing, and sales strategies.

- Develop market-entry and market expansion strategies.

- Identify, understand and capitalize on the next big thing in the US medical devices market landscape.

- Make more informed business decisions from the insightful and in-depth analysis of the US medical devices market and the factors shaping it.

 

 

 

Table of Contents

 

1 Table of Contents 5

1.1 List of Tables 6

1.2 List of Figures 6

2 Introduction 7

3 Overview of the Healthcare Reform Bill 8

4 Regulatory Landscape in the US 13

4.1 Overview of Medical Device Regulation 13

4.1.1 Establishment Registration 15

4.1.2 Medical Device Listing 15

4.1.3 New Medical Device Approval Process 16

4.1.4 Quality System Regulation/Good Manufacturing Practices 21

4.1.5 Labeling 21

4.1.6 Medical Device Reporting 22

5 Changing Reimbursement Scenario in the Medical Device Market 24

5.1 Cardiovascular Devices 24

5.1.1 Reimbursement Coverage for Transcatheter Aortic Valve Replacement 24

5.1.2 Reimbursement Coverage for Artificial Hearts and Related Devices 26

5.1.3 Reimbursement Cove
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