Abstract
The Food and Drug Administration (FDA) requires valid scientific evidence in order to determine whether there is reasonable assurance that a medical device is safe and effective for its intended use. This valid scientific evidence consists principally of well-controlled clinical investigations. This chapter will provide information on FDA regulatory requirements for controlled clinical investigations of medical devices and diagnostics, including who must conduct a clinical trial, the submissions required, and the procedures that must be followed.
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Segal, S.A. (1998). Regulatory Requirements for Clinical Trials of Medical Devices and Diagnostics. In: Witkin, K.B. (eds) Clinical Evaluation of Medical Devices. Humana Press, Totowa, NJ. https://doi.org/10.1007/978-1-4757-2756-2_4
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DOI: https://doi.org/10.1007/978-1-4757-2756-2_4
Publisher Name: Humana Press, Totowa, NJ
Print ISBN: 978-1-61737-040-3
Online ISBN: 978-1-4757-2756-2
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