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.

• Office of Device Evaluation
• Office of In-vitro Diagnostics and Radiological Health 

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

• FDA approves expanded indication for medical device to treat a form of brain cancer
• FDA allows marketing of cooling cap to reduce hair loss during chemotherapy
• FDA grants accelerated approval to new treatment for advanced ovarian cancer
• FDA approves first blood test to detect gene mutation associated with non-small cell lung cancer

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)