How to register radiation emitting Medical Devices with the CDRH

To market a medical device that emits radiation (such as X-ray, laser, ultrasound, infrared, ultraviolet) in the U.S.A. it is necessary [...]

If a product contains an electronic circuit and generates any type of radiation, it is classified as an electronic product emitting radiation. Medical [...]

The CDRH (Center for Devices and Radiological Health) is an organization within the US Food and Drug Administration (FDA) responsible for [...]