Gain market access in the United States with FDA approval

Food and Drug Administration (FDA) and Center for Devices and Radiological Health (CDRH)

USA-flagThe United States (US) Food and Drug Administration (FDA) role is to protect public health by allowing only safe and effective products to enter the market, and by monitoring products for continued safety after they are in use.

The FDA Center for Devices and Radiological Health (CDRH) is responsible for regulating companies that manufacture, repackage, re-label and/or import medical devices sold in the US.