FDA Changes Suggested in 510(k) Process - Impact and Opportunities
GlobalData’s report, “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.
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.
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