How to register radiation emitting Medical Devices with the CDRH

To market Medical Devices that emit certain types of radiation in the U.S. (see 21 CFR 1002.1 for details), a Product [...]

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 [...]