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IVDs and FDA Marketing Authorizations: A General Overview of FDA Approval Process of an IVD Companion Diagnostic Device in Oncology

  • Shyam Kalavar
  • Reena Philip
Chapter

Abstract

In vitro diagnostic devices play an important part in the field of clinical oncology by identifying patients eligible for treatment with specific targeted therapeutic products. This chapter briefly discusses the risk-based classification of in vitro diagnostic devices and the FDA regulatory review of these devices. In vitro companion diagnostic devices and the role they play in oncology clinical trials and critical elements such as the device analytical and clinical performance are also discussed. An example of a companion diagnostic device approval process is also provided.

Keywords

Risk-based classification Companion diagnostic devices Analytical performance Clinical performance Regulatory review Modular PMA 

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Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.Center for Devices and Radiological Health, Office of In Vitro Diagnostics and Radiological Health, Division of Molecular Genetics and PathologyUS Food and Drug AdministrationSilver SpringUSA

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