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.
Note: This book chapter reflects the views of the authors and should not be construed to represent FDA’s views or policies.
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Kalavar, S., Philip, R. (2019). IVDs and FDA Marketing Authorizations: A General Overview of FDA Approval Process of an IVD Companion Diagnostic Device in Oncology. In: Badve, S., Kumar, G. (eds) Predictive Biomarkers in Oncology. Springer, Cham. https://doi.org/10.1007/978-3-319-95228-4_47
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DOI: https://doi.org/10.1007/978-3-319-95228-4_47
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