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*CDRH Oncology Devices Regulatory Modernization Initiative

Forecast

Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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The CDRH Oncology Devices Regulatory Modernization Initiative is a forecast project managed by the Food and Drug Administration. Established in August 2026, the initiative aims to improve patient access to safe and effective cancer treatment medical devices by creating consistent regulatory pathways across OPEQ offices. The primary objective is to streamline the approval process and reduce the time it takes for life-saving technologies to reach the market. The workgroup is currently prioritizing devices designed to ablate or physically destroy tumors. However, there is potential for the scope to expand to include other technologies, such as devices used in neo-adjuvant settings to decrease tumor burden and enhance the overall quality of life for patients.

General Info

FDA initiative to streamline regulatory pathways for oncology devices to improve patient access.

Agency

Food and Drug Administration → Food And Drug Administration

NAICS

541618 - Other Management Consulting Services

Place of Performance

USA

Set-Aside

NONE

Documents

0

No documents available

Documents will appear here when they are available.

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Organization & Contact Information

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AgencyFood and Drug Administration → Food And Drug Administration

Contacts2 people available

OfficeN/A

Organization / AgencyFood and Drug Administration → Food And Drug Administration

Office AddressN/A

Contacts

Cdrh Acquisition Liaison

contact@example.gov

To Be Determined To Be DeterminedContracting Officer

Full Description

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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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