The marketing of Medical Devices in the USA: Regulatory Processes
This White Paper provides a comprehensive overview of the marketing of Medical Devices in the USA, focusing on device classification, pre- and post-market requirements and different types of registration procedures.
1.INTRODUCTION
Medical Devices are regulated by the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA). The FDA is the US government agency, established in 1906, that regulates medical devices as well as biological, pharmaceutical, cosmetic, food, and radiation-emitting products. […]
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