Device Trials

Heng Li (), Pamela E. Scott () and Lilly Q. Yue ()
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Heng Li: U.S. Food and Drug Administration, Center for Devices and Radiological Health
Pamela E. Scott: U.S. Food and Drug Administration, Office of the Commissioner
Lilly Q. Yue: U.S. Food and Drug Administration, Center for Devices and Radiological Health

Chapter 73 in Principles and Practice of Clinical Trials, 2022, pp 1399-1416 from Springer

Abstract: Abstract This section provides an overview of clinical studies for medical devices. Important differences between drugs and devices are highlighted. Specific topics covered include Bayesian design and observational (nonrandomized) studies. Special considerations are given to diagnostic devices.

Keywords: Medical device; FDA; Diagnostic device; Bayesian; Nonrandomized; Propensity score (search for similar items in EconPapers)
Date: 2022
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Persistent link: https://EconPapers.repec.org/RePEc:spr:sprchp:978-3-319-52636-2_102

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DOI: 10.1007/978-3-319-52636-2_102

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