The 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.
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.
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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
184.108.40.206 Premarket Notification or 510(k) 21
220.127.116.11 Premarket Approval 23
18.104.22.168 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