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

GBI Research
Published Date » 2013-05-03
No. Of Pages » N/A
   
 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...
Table of Content

1 Table of Contents 2
1.1 List of Tables 4
1.2 List of Figures 4

2 Executive Summary 5
2.1 Obtaining Marketing Clearance for Medical Devices Involves Three Essential Steps 5
2.2 The US Transcatheter Heart Valves Market is Forecast to Witness High Growth Between 2012 and 2019 due to Favorable Reimbursement 5
2.3 Strong Reimbursement Framework is Expected to Drive the US Endoscopy Device Market 6

3 Introduction 8

4 Overview of the Healthcare Reform Bill 9

5 Regulatory Landscape in the US 17
5.1 Overview of Medical Device Regulation 17
5.1.1 Establishment Registration 18
5.1.2 Medical Device Listing 19
5.1.3 New Medical Device Approval Process 19
5.1.3.1 Premarket Notification or 510(k) 21
5.1.3.2 Premarket Approval 23
5.1.3.3 Other Device Regulations 24
5.1.4 Quality System Regulation/Good Manufacturing Practices 24
5.1.5 Labeling 25
5.1.6 Medical Device Reporting 26

6 Changing Reimbursement Scenario in the Medical Device Market 28
6.1 Cardiovascular Devices 28
6.1.1 Reimbursement Coverage for Transcatheter Aortic Valve Replacement 28
6.1.1.1 Transcatheter Heart Valves Market in the US is Expected to Exceed $3 billion by 2019 at a CAGR of 45% 29
6.1.2 Reimbursement Coverage for Artificial Hearts and Related Devices 30
6.1.2.1 Left Ventricular Assist Devices Market in the US is Expected to More than Double during the Forecast Period 31
6.1.3 Reimbursement Coverage for Percutaneous Transluminal Angioplasty 32
6.2 Neurostimulation Devices 34
6.2.1 Reimbursement Coverage for Transcutaneous Electrical Nerve Stimulation 34
6.3 Diagnostic Imaging Devices 36
6.3.1 Reimbursement Coverage for Magnetic Resonance Imaging 36
6.3.2 Reimbursement Coverage for Positron Emission Tomography Scans 37
6.3.3 Reimbursement Cuts for Diagnostic Imaging Services 38
6.4 Endoscopy Devices 38
6.4.1 Reimbursement Coverage for Capsule Endoscope Systems 38
6.4.1.1 Capsule Endoscopy Systems Market in the US is Expected to Double during the Forecast Period 40

7 Appendix 43
7.1 Definitions 43
7.2 Acronyms 43
7.3 Sources 44
7.4 Research Methodology 46
7.4.1 Secondary Research 46
7.4.2 Primary Research 46
7.4.3 Models 47
7.4.4 Forecasts 47
7.4.5 Expert Panels 47
7.5 Contact Us 47
7.6 Disclaimer 48

List of Tables

Table 1: Food and Drug Administration, US, Classification Regulations 20
Table 2: Food and Drug Administration, US, Device Labeling 25
Table 3: Food and Drug Administration. US, Reporting Requirements for Manufacturers 26
Table 4: Food and Drug Administration, US, Reporting Requirements for User Facilities 26
Table 5: Transcatheter Heart Valves Market, US, Revenue Forecast ($m), 2012–2019 29
Table 6: Left Ventricular Assist Devices Market, US, Revenue Forecast ($m), 2012–2019 31
Table 7: Capsule Endoscope Systems Market, US, Revenue Forecast ($m), 2012–2019 41

List of Figures


Figure 1: Transcatheter Heart Valves Market, US, Revenue Forecast ($m), 2012–2019 6
Figure 2: Key Healthcare Reform Provisions, US, 2010 10
Figure 3: Key Healthcare Reform Provisions, US, 2010 11
Figure 4: Key Healthcare Reform Provisions, US, 2010 12
Figure 5: Key Healthcare Reform Provisions, US, 2010 13
Figure 6: Key Healthcare Reform Provisions, US, 2010 14
Figure 7: Key Healthcare Reform Provisions, US, 2010 15
Figure 8: Key Healthcare Reform Provisions, US, 2010 16
Figure 9: Key Healthcare Reform Provisions, US, 2010 16
Figure 10: Food and Drug Administration, US, Organizational Structure 17
Figure 11: Food and Drug Administration, US, Basic Regulatory Requirements 18
Figure 12: Food and Drug Administration, US, Regulations for Approval of New Medical Device 22
Figure 13: Transcatheter Heart Valves Market, US, Revenue Forecast ($m), 2012–2019 29
Figure 14: Left Ventricular Assist Devices Market, US, Revenue Forecast ($m), 2012–2019 31
Figure 15: Capsule Endoscope Systems Market, US, Revenue Forecast ($m), 2012–2019 41

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