Overview:

Summary

“FDA Changes Suggested in 510(k) Process- Impact and Opportunities” provides key information and analysis on the regulatory environment for medical devices in the US Market. The report provides information on the challenges faced by FDA while regulating the entry of medical devices into the US market and provides information on recommendations made by the Working Group formed by FDA in order to address these challenges. It provides key insights and reviews the recommended changes and its impact on medical device firms and healthcare providers. In particular, this report explains the 510(k) regulatory process and the changes that plan to be introduced to this process during the course of this year.

This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GlobalData’s team of industry experts.

Scope

- Regulatory structure of US medical devices and the challenges faced.
- The 510(k) process and its limitations.
- Working Group Recommendations and its impact.
- CDRH Plan of Action and its impact.

Reasons to buy

- Develop business strategies by understanding the regulatory and pricing related trends and developments that are affecting the medical device market in the US.
- Decide entry and market expansion strategies for the American medical equipment industry.
- Design and develop your marketing and sales strategies.

1 Table of Contents 1
1.1 List of Tables 1
1.2 List of Figures 1
2 FDA Changes Suggested in 510(k) Process - Impact and Opportunities 1
2.1 Summary 1
2.2 Regulatory Structure – Medical Devices 2
2.2.1 Food and Drug Administration 2
2.2.2 Medical Device Regulation 2
2.3 510(k) Process Reconsideration 4
2.3.1 Flaws in the 510(k) Process 4
2.4 CDRH Recommendations to be Implemented in 2011 5
2.5 Detailed Plan of Action 6
2.5.1 Impact of 510(k) Plan of Action 8
2.6 Future Outlook 9
3 Appendix 9
3.1 Research Methodology 9
3.2 Secondary Research 9
3.3 Primary Research 10
3.4 Models 10
3.5 Forecasts 10
3.6 Expert Panels 10
3.7 GlobalData Consulting 10
3.8 Contact Us 10
3.9 Disclaimer 11

1.1 List of Tables
Table 1: Impact Analysis of Expected Changes in the FDA 510 (k) Process 8

1.2 List of Figures
Figure 1: Recalls of Medical Devices, by Cause, 2005-2009 4
Figure 2: 510(k) and CE Mark Regulatory Timelines 4
Figure 3: Expected Changes in the 510 (k) Process in First Quarter of FY 2011-2012 6
Figure 4: Expected Changes in the 510 (k) Process in Second Quarter of FY 2011-2012 7
Figure 5: Expected Changes in the 510 (k) process in Third Quarter of FY 2011-2012 7