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Oncology Therapeutic and Diagnostic Devices

Oncology devices, including diagnostics, are reviewed and regulated by the Center for Devices and Radiological Health (CDRH) in partnership with the Oncology Center of Excellence (OCE).

In 2021, CDRH and OCE continued work toward our common goal of promoting innovation, provider and patient education, and patient-centered oncologic approaches. We continued to foster device innovation and advancement with our Breakthrough Devices Program, granting 13 oncology related breakthrough designations for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. We granted GI Genius, the first device that uses artificial intelligence based on machine learning to detect polyps or suspected tumors in the colon in real time during a colonoscopy. CDRH has also cleared several devices (Osartis, Stryker, and Neo Medical) to enhance pedicle screw fixation for patients with advanced tumors of the spine where fusion is not expected and the Obsidio GEM indicated for use in the embolization of hyper vascular tumors.

Continuing our role of informing and educating the public, patients, and health care providers about the benefits and risks of medical devices, CDRH updated FDA’s safety communication for robotically assisted surgical devices (RASD) reminding patients and health care providers that the safety and effectiveness of RASD for use in mastectomy procedures or in the prevention or treatment of breast cancer have not been established. Additionally, FDA took several actions to strengthen safety requirements and risk communication for breast implants which included new breast implant labeling with boxed warning for breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma.

In 2021, CDRH authorized 16 oncology-related in vitro diagnostic devices (IVDs) including 12 companion diagnostic approvals. Eight companion diagnostic devices were approved in areas of unmet need such as for the treatment of cholangiocarcinoma and to detect KRAS G12C variants in patients with non-small cell lung cancer. The first tumor agnostic immunohistochemistry companion diagnostic was authorized for the identification of patients with solid tumors that are DNA mismatch repair deficient. In addition, a second group labeling claim was approved, for patients with unresectable or metastatic melanoma to detect specific BRAF variants for the selection of BRAF inhibitors or BRAF/MEK inhibitor combinations.

Beyond companion diagnostics, four additional oncology-related IVD authorizations include Paige Prostate, the first artificial intelligence-based software device authorized in digital pathology, as well as OPKO Health 4K Score, a multi-analyte algorithmic clinical diagnostic test for prostate cancer. In addition, OncoKB was the first somatic human variant database to be recognized by FDA. This recognition supports test developers in leveraging clinical validity assertions in OncoKB to support premarket submissions for oncology tests and supports the Cancer Moonshot goals to make cancer information publicly available and to promote activities that expand cancer research.

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