*CDRH Oncology Devices Regulatory Modernization Initiative
Past New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $1,500,000 to $3,000,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- Not on record
- Points of contact
-
- CDRH Acquisition Liaison cdhracquisitions@fda.hhs.gov
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The Food and Drug Administration's Center for Devices and Radiological Health is procuring regulatory modernization services to support the CDRH Oncology Devices Workgroup, established in August 2026 to increase access to safe and effective cancer treatment devices. The engagement focuses initially on establishing clear, consistent regulatory pathways for devices intended to ablate or physically destroy tumors, with scope expansion potential to include neo-adjuvant devices designed to reduce tumor burden and improve quality of life. The solicitation is estimated to release on July 1, 2026, with award targeted for January 1, 2027.
The estimated award value ranges from $1.5 million to $3 million, addressing FDA's objective to reduce time to market for potentially life-saving oncology devices while maintaining regulatory consistency across OPEQ offices. Inquiries should be directed to the FDA's Center for Devices and Radiological Health at cdhracquisitions@fda.hhs.gov.
Forecast text
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).
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