*CDRH Oncology Devices Regulatory Modernization Initiative

The CDRH oncology devices workgroup was established in August 2026 with the goal of increasing access to safe and effective medical devices for cancer patients. The workgroup will establish clear regulatory pathways for devices used in cancer management that can be applied consistently across OPEQ offices and seeks to reduce time to market for these potentially life-saving devices. The initial focus of the workgroup is on devices intended to ablate or physically destroy tumors, with potential to expand the scope to other technology types (e.g., devices that are intended to be used in neo-adjuvant settings to reduce tumor burden and improve quality of life).