What is the role of the Center for Devices and Radiological Health?

The Center for Devices and Radiological Health (CDRH) plays a crucial role in the regulation and oversight of medical devices and radiological products, ensuring their safety and effectiveness before they can be marketed to the public. This center is responsible for evaluating premarket submissions, conducting postmarket surveillance, and monitoring the performance of devices once they are on the market to ensure that they continue to meet safety and effectiveness standards.

By focusing on device evaluation, the CDRH ensures that all medical devices, including diagnostic equipment, surgical instruments, and in vitro diagnostic devices, meet rigorous regulatory standards designed to protect public health. This involves reviewing clinical data, conducting risk assessments, and assuring compliance with relevant regulations.

In contrast, the other options pertain to areas outside the CDRH's primary focus. Evaluating biologics is handled by the Center for Biologics Evaluation and Research, assessing drug interactions is primarily the responsibility of the Center for Drug Evaluation and Research, and reviewing clinical trial protocols typically falls under the purview of Institutional Review Boards and other regulatory bodies rather than the CDRH specifically.