What are FDAs role and responsibilities with regard to regulating medical devices?
FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating companies that manufacture, repackage, re-label, perform specified processes, and/or import medical devices sold in the United States. Foreign establishments that export devices into the United States are also required to list their devices with FDA and are subject to on-site inspections. The CDRH also regulates radiation-emitting electronic products (both medical and non-medical) such as lasers, x-ray systems, and ultrasound equipment.
