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  1. Oncology Center of Excellence

Oncology Devices and Diagnostics

Oncology Devices and Diagnostics include a range of medical devices, in vitro diagnostics and combination device products that assist patients and providers in screening, diagnosing, treating, and monitoring premalignant and malignant conditions.
These products are reviewed in partnership with OCE by FDA’s Center for Devices and Radiological Health.

Some examples of cleared/approved Oncology Devices and Diagnostics include the following:

For a complete list of FDA cleared or approved companion diagnostic devices (In Vitro and Imaging Tools) please see: List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools)

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