CDRH

The Center for Devices and Radiological Health (CDRH) is the branch of the FDA responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices. The definition of a medical device is given in the FD&C Act.

CDRH regulatory powers include the authority to require certain technical reports from the manufacturers or importers of regulated products, to declare regulated products defective, and to order the recall of defective or noncompliant products.
CDRH also conducts limited amounts of direct product testing.