What does FDA Center For Devices And Radiological Health do?

The FDA Center for Devices and Radiological Health (CDRH) is dedicated to ensuring the safety, effectiveness, and security of medical devices and radiation-emitting products through science-driven regulatory oversight. Its core mission centers on advancing public health by evaluating emerging technologies, supporting innovation in medical device design, and strengthening post-market surveillance systems. Strategic priorities include enhancing cybersecurity for connected devices, improving clinical data integrity through annotated pathological datasets, and developing robust software validation frameworks to mitigate risks in medical software ecosystems. CDRH actively funds research into immune responses to implantable materials and maintains critical databases for software component risk analysis, reflecting a deep commitment to evidence-based regulation grounded in biotechnology and analytical science. The agency primarily procures research and development services in biotechnology and life sciences, alongside custom software programming and analytical instrument manufacturing. Contract structures frequently involve sole-source awards for ongoing research continuity, combined solicitations for integrated solutions, and sources-sought notices to explore innovative vendor capabilities. Procurements are often tied to specific regulatory science initiatives requiring specialized technical expertise and validated methodologies. CDRH’s procurement activity is heavily concentrated in NAICS 541714 (biotechnology R&D) and 541715 (life sciences R&D), with consistent demand for custom programming services to support data systems and risk analytics. The agency actively prioritizes small business set-asides, particularly through SBA programs, and has demonstrated targeted support for 8(a) participants in media production and management consulting. Vendor relationships are built around niche technical capabilities, with preference for firms capable of delivering compliant, reproducible, and auditable scientific outputs. As a center within the Food and Drug Administration under the Department of Health and Human Services, CDRH operates nationally with no fixed physical headquarters, coordinating regulatory science activities across federal, academic, and industry partners. It leverages a mix of indefinite-delivery/indefinite-quantity (IDIQ) vehicles, direct awards, and competitive solicitations to meet its mission-critical science and technology needs.

What contracts does FDA Center For Devices And Radiological Health award?

FDA Center For Devices And Radiological Health awards government contracts across various categories. Browse contract opportunities from this agency.

How do I do business with FDA Center For Devices And Radiological Health?

To do business with FDA Center For Devices And Radiological Health, start by registering in SAM.gov and obtaining a UEI number. Then search for contract opportunities from this agency on CLEATUS. Review the agency's procurement history, identify relevant NAICS codes, and prepare competitive proposals. The contractors tab shows companies that have won contracts from this agency.

Who are the top contractors for FDA Center For Devices And Radiological Health?

View the full list of contractors who have won awards from FDA Center For Devices And Radiological Health in the contractors tab . You can filter by contract value, NAICS code, and set-aside type to find relevant competitors and potential teaming partners.

What set-aside programs does FDA Center For Devices And Radiological Health use?

FDA Center For Devices And Radiological Health uses 3 different set-aside programs, including Total Small Business Set-Aside (FAR 19.5), 8(a) Sole Source, and 8a Competed. These programs reserve a portion of contracts for qualifying businesses. View the set-aside breakdown on the agency overview.

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Federal Agency· 75DKKW

FDA Center For Devices And Radiological Health

Part of Department Of Health And Human Services

The FDA Center for Devices and Radiological Health (CDRH) is dedicated to ensuring the safety, effectiveness, and security of medical devices and radiation-emitting products through science-driven regulatory oversight. Its core mission centers on advancing public health by evaluating emerging technologies, supporting innovation in medical device design, and strengthening post-market surveillance systems.

FDA Center For Devices And Radiological Health

Part of Department Of Health And Human Services

Leadership and vacancies

Recent FDA Center For Devices And Radiological Health Contracts

Software Bill of Materials (SBOM) Validation Comparison Set

Software Component Package Risk & Vulnerability Periodic Database

Software Component Package Risk & Vulnerability Periodic Database

FDA Request for Information for Studio Video Media Production Services

supports research to create datasets of pathologist annotations

FDA (CDRH) Ragan Build Better Writers Program (Brand Name or Equal)

The Food and Drug Administration intends to make a sole source award for the continuation of a research and development project to maintain and update previously published materials safety reports.

Patient Samples of Medical Device Implantation

Medical Device Active Surveillance System

Sources Sought: Study to understand how medical device implantation alters local and/or systemic immune response relative to implanted metal-alloy devices.

Search all FDA Center For Devices And Radiological Health contracts

Search all FDA Center For Devices And Radiological Health contractors

Frequently Asked Questions

What does FDA Center For Devices And Radiological Health do?

What contracts does FDA Center For Devices And Radiological Health award?

How do I do business with FDA Center For Devices And Radiological Health?

Who are the top contractors for FDA Center For Devices And Radiological Health?

What set-aside programs does FDA Center For Devices And Radiological Health use?

Recently Posted by FDA Center For Devices And Radiological Health

Get AI-powered intelligence on FDA Center For Devices And Radiological Health procurement

Recently Posted by FDA Center For Devices And Radiological Health

Leadership and vacancies

Recent FDA Center For Devices And Radiological Health Contracts

Software Bill of Materials (SBOM) Validation Comparison Set

Software Component Package Risk & Vulnerability Periodic Database

Software Component Package Risk & Vulnerability Periodic Database

FDA Request for Information for Studio Video Media Production Services

supports research to create datasets of pathologist annotations

FDA (CDRH) Ragan Build Better Writers Program (Brand Name or Equal)

The Food and Drug Administration intends to make a sole source award for the continuation of a research and development project to maintain and update previously published materials safety reports.

Patient Samples of Medical Device Implantation

Medical Device Active Surveillance System

Sources Sought: Study to understand how medical device implantation alters local and/or systemic immune response relative to implanted metal-alloy devices.

Search all FDA Center For Devices And Radiological Health contracts

Search all FDA Center For Devices And Radiological Health contractors

Frequently Asked Questions

What does FDA Center For Devices And Radiological Health do?

What contracts does FDA Center For Devices And Radiological Health award?

How do I do business with FDA Center For Devices And Radiological Health?

Who are the top contractors for FDA Center For Devices And Radiological Health?

What set-aside programs does FDA Center For Devices And Radiological Health use?