Regulatory Requirements for Clinical Trials of Medical Devices and Diagnostics

  • Sharon A. Segal

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.

Keywords

Medical Device Supplemental Application Device Evaluation Investigational Device Exemption Unanticipated Adverse Effect 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Springer Science+Business Media New York 1998

Authors and Affiliations

  • Sharon A. Segal

There are no affiliations available

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