What is one major goal of the FDA's pre-market review process?

What is one major goal of the FDA's pre-market review process?

• A. To expedite the development of generic drugs
• B. To evaluate safety and effectiveness of new medical devices
• C. To reduce manufacturing costs for producers
• D. To promote international collaboration in device development

Answer: (B)

The primary goal of the FDA's pre-market review process is to evaluate the safety and effectiveness of new medical devices before they can be marketed to the public. This thorough review ensures that devices meet established standards and are adequately tested for their intended use and potential risks. The intention is to protect public health by ensuring that only devices meeting specific safety and effectiveness criteria can be sold and used. This process involves a comprehensive assessment of clinical data, labeling information, and manufacturing processes. By focusing on these aspects, the FDA helps to ensure that medical devices not only perform as intended but also do not pose unacceptable risks to users. The pre-market evaluation is crucial, especially as technological advancements lead to more complex and innovative devices in the market. Thus, the emphasis on safety and effectiveness is paramount in regulatory practices governing medical devices.

The primary goal of the FDA's pre-market review process is to evaluate the safety and effectiveness of new medical devices before they can be marketed to the public. This thorough review ensures that devices meet established standards and are adequately tested for their intended use and potential risks. The intention is to protect public health by ensuring that only devices meeting specific safety and effectiveness criteria can be sold and used.

This process involves a comprehensive assessment of clinical data, labeling information, and manufacturing processes. By focusing on these aspects, the FDA helps to ensure that medical devices not only perform as intended but also do not pose unacceptable risks to users. The pre-market evaluation is crucial, especially as technological advancements lead to more complex and innovative devices in the market. Thus, the emphasis on safety and effectiveness is paramount in regulatory practices governing medical devices.