ResearchMoz

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

Upcoming Reports:

Gas Turbine Electrical Power Generation Market - Global Industry Analysis, Size, Share, Trends, Analysis, Growth And Forecast, 2013 - 2019
By - Transparency Market Research
The use of gas turbines for generating electricity is a technology dating back many years. These turbines are a kind of internal combustion (IC) engine where an air fuel mixture is burnt to generate hot gases. The hot gases are then used to rotate this turbine and in turn generate electricity. Such turbines are able to combust a large variety of fuels like natural gas, fuel oil and other synthetic oils. Power generation through gas turbines still remains one of the cleanest forms of energy, with very low levels of emission.  The high quality of exhaust heat from such turbines...
Poland: market of machinery for sorting, screening, separating, washing, crushing, mixing machines for mineral substances
By - Williams and Marshal Strategy
This report presents a comprehensive overview of the machinery for sorting, screening, separating, washing, crushing, mixing machines for mineral substances market in Poland and its state as of January 2014. It provides detailed analysis of the industry, its dynamics and structure. The purpose of the report is to describe the state of the machinery for sorting, screening, separating, washing, crushing, mixing machines for mineral substances market in Poland, to present actual and retrospective information about the volumes and dynamics of production, imports, exports and consumption, the...
Greece: rabbit meat market
By - Williams and Marshal Strategy
This report presents a comprehensive overview of the rabbit meat market in Greece and its state as of January 2014. It provides detailed analysis of the industry, its dynamics and structure. The purpose of the report is to describe the state of the rabbit meat market in Greece, to present actual and retrospective information about the volumes and dynamics of production, imports, exports and consumption, the characteristics of the market for the period 2008-2012 and to build a forecast for the market development until 2018. In the same way, the report presents an elaborate overview of the...

Research Assistance

We will be happy to help you find what you need.
Please call us or write us:

866-997-4948 (Us-Canada Toll Free)
Tel: +1-518-618-1030
Email: sales@researchmoz.us
Select License type:

Share this report

Related News

OnePlus One ready to launch it smart phone in India
Jul 28, 2014  
Chinese smart phones are gaining popularity in the Indian market. OnePlus, a Chinese smart phones company, is ready to launch the invitation-only One smart phone in India.  Many Chinese smart phone brands have got inspired by the success of another smart phone brand called Xiaomi which had successfully launched the Mi 3, a smart phone in the Indian market. The OnePlus One is a typical...
Danone all set to sell its business to Hospira
Jul 28, 2014  
According to the Financial Times, Danone, a French dairy group is aiming at selling its business pertaining to medical nutrition to Hospira, a US group. The deal value is estimated at $ 5 billion.  The plan is still in the pipeline as nothing with respect to the business is fully confirmed or certain. Representatives of neither business groups were willing to comment on the same. ...
At a USD 62 Price Tag, the Karbonn A50S Smartphone Could Challenge Likes of Apple and Samsung in India
Jul 28, 2014  
A USD 62 smartphone launched in the Indian market by Karbonn could signal stiff competition for behemoths such as Apple that makes the iPhone and Samsung, known best for its Galaxy smartphone range. The Karbonn A50S, which has been officially launched in India, can also be ordered by customers outside of the country via online stores, and delivered to their doorstep. Given its exceptionally...
Loss recorded due to heavy investments carried out by Amazon
Jul 25, 2014  
Amazon.com Inc has been investing in newer businesses like consumer electronics and digital content, due to which it has been running into losses for some time now. The loss recorded in the second quarter was by far the highest. In 2014, the stock prices have dropped by 10% with reduced investor confidence in the long term growth investments. The shares of this US based online retailer...
LG Electronics To Invest Huge Capital in R&D Project in South Korea
Jul 25, 2014  
LG Electronics Inc will invest USD 1.26 billion in the construction of a new research and development unit in South Korea’s capital city Seoul. The facility is said to be part of LG’s Science Park project. The 170,000 square meters site will be built in Magok, Seoul and work is expected to begin from August. Once the construction is complete and ready by 2020, the park will house...