Exporting medical devices to the USA a practical guide to the FDAregulations. “Routes to product compliance”

摘要

Provides an overview of the regulatory routes available to medicaldevice manufacturers who wish to obtain approval from the Food and DrugAdministration (FDA) in order to market their products in the U.S.A. Thefollowing topics are covered: pre-requisites; registering theestablishment; listing the devices; obtaining FDA approval; complyingwith the quality system regulation