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Biodesign by Paul Yock, Josh Makower, Stefanos Zenios

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4.2 Regulatory Basics

Introduction
Without regulatory clearance by the FDA (or the equivalent agency abroad) even the most innovative and important breakthrough in medical technology will never reach patients. The issues involved in determining the safety and effectiveness of a new technology are often complex –; and the data on which decisions are made are never perfect. Innovators can lose patience with a process that seems vague, arbitrary, and interminable, while FDA reviewers can lose sleep over the prospect of approving a device that may someday do unexpected harm to patients.
Because of the critically important role that regulatory issues play in the ultimate success of a new technology, understanding the regulatory pathway is imperative, ...

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