Exporting medical devices to the USA a practical guide to the FDA regulations. 'Routes to product compliance'

摘要

Provides an overview of the regulatory routes available to medical device manufacturers who wish to obtain approval from the Food and Drug Administration (FDA) in order to market their products in the U.S.A. The following topics are covered: pre-requisites; registering the establishment; listing the devices; obtaining FDA approval; complying with the quality system regulation.