International Information (Devices)
Within FDA, the Center for Devices and Radiological Health (CDRH) develops and implements national programs to protect the public health in the fields of medical devices and radiological health. These programs are intended to assure the safety, effectiveness, and proper labeling of medical devices; to promote quality in mammographic services; and to control unnecessary human exposure to potentially hazardous radiation and ensure the safe, efficacious use of such radiation. The Center reviews and evaluates medical device premarket approval (PMA) applications, exemption requests for investigational devices (IDEs), and premarket notifications [510(k)s]. CDRH also develops and enforces performance standards for medical devices and radiation-emitting electronic products and GMP regulations.
Under the Safe Medical Devices Act of 1990, CDRH has established an International Staff to coordinate the development of agreements with foreign countries in order to facilitate trade in devices.