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Overview of What We Do

FDA's Center for Devices and Radiological Health is responsible for ensuring the safety and effectiveness of medical devices and eliminating unnecessary human exposure to man-made radiation from medical, occupational and consumer products. There are thousands of types of medical devices, from heart pacemakers to contact lenses. Radiation-emitting products regulated by FDA include microwave ovens, video display terminals, and medical ultrasound and x-ray machines. The center accomplishes its mission by:

• reviewing requests to research or market medical devices
• collecting, analyzing, and acting on information about injuries and other experiences in the use of medical devices and radiation-emitting electronic products
• setting and enforcing good manufacturing practice regulations and performance standards for radiation-emitting electronic products and medical devices
• monitoring compliance and surveillance programs for medical devices and radiation-emitting electronic products
• providing technical and other nonfinancial assistance to small manufacturers of medical devices.

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Center for Devices and Radiological Health / CDRH