Which of the Following Is True Regarding FDA Approval of Medical

question 54

Multiple Choice

Which of the following is true regarding FDA approval of medical devices in relation to state law claims for failure to warn?

• A) FDA approval of medical devices does not preempt state failure-to-warn claims arising out of injuries caused by the device.
• B) FDA approval of medical devices preempts state failure-to-warn claims arising out of injuries caused by the device,regardless of whether the device was exempted from full review.
• C) FDA approval of medical devices preempts state failure-to-warn claims arising out of injuries caused by the device,unless the device was exempted from full review.
• D) FDA approval of certain medical devices does not preempt state failure-to-warn claims arising out of injuries caused by the device,but federal law preempts state failure-to-warn claims related to nonapproved devices.

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Definitions:

Customer Satisfaction

The degree to which a product or service meets or exceeds the customer's expectations.

Customer Needs

The requirements or desires of consumers that companies aim to meet with their products or services.

Process Reengineering

The radical redesign of core business processes to achieve dramatic improvements in productivity, efficiency, and quality.

Total Quality Management

An organizational approach focusing on continuous improvement in all aspects of business, aimed at achieving long-term customer satisfaction.