The U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States.

Before granting approval to manufacturers to sell their new devices, FDA science experts review the manufacturers data from investigational studies to see if:

• the product does what it claims to do effectively, and
• does not present any unreasonable risks to the user