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

The primary role of the FDA Center for Devices and Radiological Health (CDRH) is to regulate medical devices and ensure their safety and effectiveness for public health. This involves evaluating new medical devices before they can be marketed, enforcing standards for device manufacturing, and overseeing the post-market surveillance of devices to ensure they remain safe and effective throughout their lifecycle. The CDRH also issues guidelines and regulations that the medical device industry must follow to mitigate potential risks to patients.

While promoting medical device innovations and overseeing sales operations are important aspects of the medical device ecosystem, they are not the central mission of the CDRH. The manufacturing of medical devices is primarily the responsibility of the device manufacturers themselves, not the CDRH. Moreover, while the CDRH may support innovation through various initiatives, the core function is focused on regulation and safety assurance.