Changing Regulatory and Reimbursement Scenario for Medical Devices in the US Market

Summary

GBI Research’s report “Changing Regulatory and Reimbursement Scenario for Medical Devices in the US Market” looks at the regulatory landscape and reimbursement scenario in the US for four medical device markets: cardiovascular devices, neurostimulation devices, diagnostic imaging devices and endoscopy devices. The report provides comprehensive information on establishment registration, medical device listing, Premarket Notification (510k) or Premarket Approval (PMA), Investigational Device Exemption (IDE) for clinical studies, Quality System (QS) regulation, labeling requirements, and Medical Device Reporting (MDR). The report also reviews the reimbursement scenario in these medical device markets. It is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research’s team of industry experts.

Scope

- The report analyzes the regulatory and reimbursement scenario for medical devices in the US.
- Information on the regulatory landscape in the US: establishment registration, medical device listing, Premarket Notification (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
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 Coverage for Percutaneous Transluminal Angioplasty 28
5.2 Neurostimulation Devices 30
5.2.1 Reimbursement Coverage for Transcutaneous Electrical Nerve Stimulation 30
5.3 Diagnostic Imaging Devices 32
5.3.1 Reimbursement Coverage for Magnetic Resonance Imaging 32
5.3.2 Reimbursement Coverage for Positron Emission Tomography Scans 33
5.3.3 Reimbursement Cuts for Diagnostic Imaging Services 33
5.4 Endoscopy Devices 34
5.4.1 Reimbursement Coverage for Capsule Endoscope Systems 34
6 Appendix 38
6.1 Definitions 38
6.1.1 Cardiovascular Devices 38
6.1.2 Diagnostic Imaging 38
6.1.3 Neurostimulation Devices 38
6.1.4 Endoscopy Devices 38
6.2 Acronyms 38
6.3 Sources 39
6.4 Research Methodology 41
6.4.1 Secondary Research 41
6.4.2 Primary Research 41
6.4.3 Models 42
6.4.4 Forecasts 42
6.4.5 Expert Panels 42
6.5 Contact Us 42
6.6 Disclaimer 42

List of Tables

Table 1: Food and Drug Administration, US, Classification Regulations 16
Table 2: Food and Drug Administration, US, Device Labeling 21
Table 3: Food and Drug Administration. US, Reporting Requirements for Manufacturers 22
Table 4: Food and Drug Administration, US, Reporting Requirements for User Facilities 22
Table 5: Transcatheter Heart Valves Market, US, Revenue Forecast ($m), 2012-2019 25
Table 6: Left Ventricular Assist Devices Market, US, Revenue Forecast ($m), 2012-2019 27
Table 7: Capsule Endoscope Systems Market, US, Revenue Forecast ($m), 2012-2019 36

List of Figures

Figure 1: Key Healthcare Reform Provisions, US, 2010A 8
Figure 2: Key Healthcare Reform Provisions, US, 2010B 9
Figure 3: Key Healthcare Reform Provisions, US, 2010C 9
Figure 4: Key Healthcare Reform Provisions, US, 2010D 10
Figure 5: Key Healthcare Reform Provisions, US, 2010E 10
Figure 6: Key Healthcare Reform Provisions, US, 2010F 11
Figure 7: Key Healthcare Reform Provisions, US, 2010G 11
Figure 8: Key Healthcare Reform Provisions, US, 2010H 12
Figure 9: Food and Drug Administration, US, Organizational Structure 13
Figure 10: Food and Drug Administration, US, Basic Regulatory Requirements 14
Figure 11: Food and Drug Administration, US, Regulations for Approval of New Medical Device 18
Figure 12: Transcatheter Heart Valves Market, US, Revenue Forecast ($m), 2012-2019 25
Figure 13: Left Ventricular Assist Devices Market, US, Revenue Forecast ($m), 2012-2019 27
Figure 14: Capsule Endoscope Systems Market, US, Revenue Forecast ($m), 2012-2019 36

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