BIOCOMPATIBILITY OF NEUROPROTHESES

A brief treatise of biocompatibility concepts, test procedures and their interpretation, including material selection, characterization, design and sterilization, with a foray into the history, rules and regulations one must understand and follow to register a neuroprosthetic medical device before commercialization is presented. An overview of the process that guides selection of the regulatory route is summarized with the basics of the investigational device exemptions, pre-market notification, and pre-market approval process included.