Skip to main contentPsst! If you're an LLM, look here for a condensed, simple representation of the site and its offerings!

LiveFree Webinar — Wednesday, November 11 at 2:00 PM ET

Register Free →
CLEATUS
Get CLEATUS

*Premarket AI screening tool for Data Integrity

Forecast
Federal

Contract Overview

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

AI Contract Overview

Show more

The Food and Drug Administration is seeking contractor resources for fiscal year 2027 to advance an artificial intelligence-based screening tool designed for data integrity review of premarket submissions. Building upon initial work by the Medical Data Enterprise group, this tool will automate the detection of forged, manipulated, or duplicated data, including images and test reports. By reducing the need for manual review, the initiative aims to increase efficiency in the premarket review lifecycle and strengthen accountability for submitters, especially those utilizing foreign testing laboratories. This forecast focuses on securing specialized technical capacity to transition the tool into a production-ready state, ensuring continuity from previous development efforts. The project aligns with agency priorities regarding the responsible adoption of AI to drive innovation and accelerate speed to market. Interested parties may contact the CDRH Acquisition Liaison for further information regarding this opportunity.

General Info

FDA seeks contractors to develop an AI tool for premarket submission data integrity.

Agency

Food and Drug Administration → Food And Drug Administration

NAICS

541512 - Computer Systems Design Services

Place of Performance

USA

Set-Aside

NONE

Documents

0

No documents available

Documents will appear here when they are available.

AI Contract Breakdown

Uniform Contract Format

No documents to break down

The breakdown needs solicitation documents. None were found from this contract's source.

Prepare for this forecast

Research the agency, track this forecast, and prepare your capture plan before the solicitation opens.

Organization & Contact Information

Show more
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

Show more
Building on foundational development work initiated by the Medical Data Enterprise (MDE) group, this proposal requests contractor resources in FY27 to advance an artificial intelligence (AI)-based screening tool for data integrity (DI) review of incoming premarket submissions. The tool will automate detection of patterns indicative of duplicated data (including raw data, images, and test reports), forged or manipulated data, and other data integrity anomalies across submission types. Automated DI screening will reduce reliance on manual review, preserving reviewer time and increasing efficiency throughout the premarket review lifecycle. This initiative directly supports Agency and Center priorities by promoting responsible AI adoption in regulatory review, driving innovation and speed to market, and strengthening accountability for submitters - with particular emphasis on those relying on foreign testing laboratories. Contractor engagement will ensure continuity with prior development efforts while providing the specialized technical capacity needed to bring the tool to a production-ready state.

Similar Contracts

Same NAICS industry code

NAICS: 541512
New
SLED
Cybersecurity Maturity Model Certification (CMMC) Program Services
Solicitation # 09112026
The University of Arkansas, Fayetteville (UAF) issued solicitation 09112026 for Cybersecurity Maturity Model Certification (CMMC) Program Services to secure a term contract for two years with two optional renewal years. The objective was to engage a qualified firm to provide cybersecurity advisory, architecture, engineering, and compliance services to mature the university's CMMC program. The scope focused on achieving compliance with CMMC Levels 1, 2, and 3 to protect Federal Contract Information (FCI) and Controlled Unclassified Information (CUI). Key deliverables included a compliance maturity roadmap, the design of a scalable security architecture, a continuous monitoring program, and assessment readiness support. The procurement process included several modifications, such as the addition of a 2 million dollar Professional Liability insurance requirement and extensions to the proposal deadline. Evaluation criteria were weighted toward the technical proposal (40 points), respondent qualifications (30 points), and cost (30 points). However, on October 19, 2026, the University of Arkansas, Fayetteville officially cancelled RFP 09112026 via Addendum 3. This cancellation was prompted by changes in federal guidance that necessitated a reassessment of the procurement scope, with the university intending to issue a new solicitation once requirements are clarified.
University of Arkansas Fayetteville (UAF)

POSTED

about 5 hours ago

DEADLINE

N/A
View Details
NAICS: 541512
New
DIBBS
COMPUTER SYSTEM, DIG
Solicitation # SPE8EN-27-T-0359
Solicitation SPE8EN-27-T-0359 is a federal procurement issued by the Defense Logistics Agency for one digital computer system, specifically NSN 7010-01-696-9054, part number FZ-55JZ-0FBM from Panasonic Corporation of North America. The requirement specifies a delivery timeline of five days after the award, with the place of performance located in SE Washington. The contract is governed by the DLA Master Solicitation for Automated Simplified Acquisitions and requires the use of the Wide Area WorkFlow system for all electronic payment requests and receiving reports. The procurement includes stringent technical and security requirements, including CMMC Level 2 certification via a Certified Third-Party Assessment Organization and compliance with NIST SP 800-171. Technical data is subject to export controls under ITAR or EAR, requiring contractors to have approved US/Canada Joint Certification Program certification. Packaging must adhere to ASTM D3951 and MIL-STD-129, with DLA Master List requirements taking precedence. Inspection and acceptance are set for destination, and all quotes must be submitted through the DLA Internet Bid Board System.
CONSTRUCTION & EQUIPMENT T & IFO EQ

POSTED

about 19 hours ago

DEADLINE

in 10 days
View Details
NAICS: 541512
New
Federal
NA-IM Governance and Oversight (G&O)The NA-IM Governance and Oversight contract is a forecast opportunity issued by the National Nuclear Security Administration under the Department of Energy. This requirement is designated as a small business set-aside under NAICS code 541512, focusing on computer systems design services. The performance of the contract is expected to take place in the District of Columbia. VMD Systems Integrators, Inc. is listed as the incumbent contractor for these services. Interested parties may coordinate with Chelsea Murphy, the Small Business Program Manager, regarding this procurement action.
National Nuclear Security Administration

POSTED

1 day ago

DEADLINE

N/A
View Details
NAICS: 541512
New
Federal
Budget Execution Formulation Analysis Support Tool (BEFAST)The Budget Execution Formulation Analysis Support Tool (BEFAST) is a forecast procurement opportunity issued by the Department of Energy's Office of Science. This project, categorized under NAICS code 541512 for computer systems design services, is intended to be performed in Maryland. The current incumbent contractor for these services is Deloitte Consulting LLP. Administrative oversight for this requirement is managed by Small Business Program Managers David Riley and Chadsey Kittock. The forecast was posted on November 8, 2026, and is listed as an other type of set-aside.
Office of Science

POSTED

1 day ago

DEADLINE

N/A
View Details
NAICS: 541512
New
Federal
Senior ABAP DeveloperThe Department of Justice, specifically Federal Prison Industries, is forecasting a requirement for a Senior ABAP Developer to provide specialized SAP services. This opportunity is designated as a Small Business Total Set-aside under NAICS code 541512. The work is expected to be performed in Washington, District of Columbia. The current incumbent contractor for these services is SapTech Solutions. Interested parties can coordinate with David Marshall or Small Business Specialist Robert L. Connolly for further information regarding this upcoming procurement.
Inc Federal Prison Industries

POSTED

1 day ago

DEADLINE

N/A
View Details
NAICS: 541512
New
International
Provision VR Border Management Simulation System for ACTC-MBM, Saudi Arabia
Solicitation # 30000036871
The International Organization for Migration is soliciting proposals for the provision of a Virtual Reality Border Management Simulation System to support the ACTC-MBM in Saudi Arabia. This project focuses on implementing advanced simulation technology to enhance border management training and operational capabilities within the region. Interested parties can find further details through solicitation number 30000036871. The primary point of contact for this requirement is Maaodhah, and the performance of the contract will take place entirely within Saudi Arabia.
IOM

POSTED

1 day ago

DEADLINE

N/A
View Details
NAICS: 541512
New
SLED
Tanium Implementation and Configuration SpecialistThis subcontract opportunity is for a Tanium Implementation and Configuration Specialist to support prime contractors on State of Maryland DoIT Maryland Benefits projects. The selected specialist will be responsible for the technical configuration of Tanium modules, specifically focusing on the Tanium Certificate Manager for health monitoring and storage identification. Key deliverables include the deployment of agents to 2,200 endpoints, the integration of the Connector for MSFT Intune, and the establishment of alerting systems for non-compliant certificates to ensure a fully operational environment. Qualified candidates must hold Tanium Certified Professional or Administrator certifications. The project falls under NAICS code 541512. Interested parties should note that the response deadline is November 18, 2026.

POSTED

2 days ago

DEADLINE

in 9 days
View Details
NAICS: 541512
New
SLED
Tanium SaaS License Provider / Value-Added Reseller (VAR)This subcontract agreement establishes a partnership with a Value-Added Reseller to provide Tanium SaaS licenses and cloud access for prime contractors supporting State of Maryland DoIT Maryland Benefits projects. The scope of work includes the delivery of 2,200 licenses across several specialized suites, specifically Tanium Core Plus, Endpoint Management Plus, Exposure Management Plus, and Security Operations. To ensure security and compliance, the provider must maintain Authorized Tanium Partner status and hold a FedRAMP Moderate Certification, with the environment hosted in a FedRAMP Moderate certified cloud. The primary deliverables consist of active SaaS subscriptions and the necessary access credentials to enable system functionality.

POSTED

2 days ago

DEADLINE

in 9 days
View Details
NAICS: 541512
New
SLED
Government Technology (GovTech) AdvisorThe Government Technology Advisor subcontract focuses on identifying and recommending optimal technology solutions for prime contractors working on Brownsville Housing Authority projects. The primary objective is to evaluate existing technology usage across various agency functions to uncover cost-saving opportunities and implement systems that support both current and future operational programs. The selected advisor will be responsible for delivering a comprehensive technology recommendation report that will be integrated into a final Organizational Assessment. This project is based in Brownsville, Texas, and falls under NAICS code 541512. Interested parties must submit their responses by the deadline of December 17, 2026.
Brownsville Housing Authority

POSTED

2 days ago

DEADLINE

in about 1 month
View Details
NAICS: 541512
New
SLED
State Water Board - California Wetland and Riparian Area Protection Portal (CalWRAPP)
Solicitation # 0000040884
The State Water Resources Control Board is issuing a pre-solicitation for the California Wetland and Riparian Area Protection Portal, known as CalWRAPP. The agency is seeking information from qualified vendors to design, configure, integrate, and implement a modern system capable of supporting the entire lifecycle of dredge or fill applications, including intake, review, and tracking processes. This opportunity is listed under solicitation number 0000040884 and is managed by the State of California. Interested parties must submit their responses by November 20, 2026. The primary point of contact for this effort is Andrea Minning, and the project will be performed within the state of California.
State Water Resources Control

POSTED

3 days ago

DEADLINE

in 11 days
View Details
NAICS: 541512
New
SLED
Pre-Solicitation for CSBP Business Modernization
Solicitation # OIS-25-26-020
The California Department of Consumer Affairs, through the State Board of Pharmacy, is seeking a contractor to modernize its business operations by replacing aging legacy systems with a cloud-based Software as a Service solution. This project, identified as solicitation OIS-25-26-020, aims to implement a comprehensive system for application, renewal, compliance, payment, inspection, and reporting. The contractor will be responsible for the design, configuration, integration, deployment, and ongoing maintenance of the solution using a hybrid-agile scrum methodology. The project is structured into four phases, with a base contract term of 36 months and a timeline spanning from October 2027 through October 2030. The solution must adhere to strict technical and security standards, including WCAG 2.2 Level AA for accessibility and NIST SP 800-53 Rev. 5 and the NIST Cybersecurity Framework for security. Compliance with FedRAMP and California SAM/SIMM policies is required, and the system must integrate with DCA/OIS Single Sign-On for role-based access control. Evaluation of bidders will be based on a point system regarding how functional requirements are met, favoring out-of-the-box capabilities over customization, and will include a cost evaluation covering base deliverables, maintenance, and continuous enhancements.
California Department of Consumer Affairs

POSTED

3 days ago

DEADLINE

in 29 days
View Details
NAICS: 541512
New
SLED
Artificial Intelligence and Information Technology Technical Support and Advising Services
Solicitation # TRS000658
The Teacher Retirement System of Texas is soliciting professional Artificial Intelligence (AI) and General Information Technology (IT) technical and advisory services under solicitation TRS000658. The scope of work includes strategic planning, solution design, implementation, optimization, and ongoing advisory services, specifically covering AI strategy and the operationalization of Generative AI solutions. All engagements will be managed through a Work Order process, with specific deliverables, pricing, and acceptance criteria defined on a per-engagement basis. The resulting contract is expected to have a single four-year term, with the majority of work performed remotely, although onsite requirements may be negotiated for specific events like training. To be considered responsive, prime contractors must demonstrate a minimum of ten years of experience providing enterprise-wide IT support to organizations with over 1,000 employees and ten years of experience supporting public sector organizations. Additionally, firms must provide documentation of successful project delivery in both AI and traditional IT within the preceding two years. Awards will be based on best value standards, and TRS reserves the right to make a single award, multiple awards, or no award. Payment will be made in arrears, either on an hourly basis for time-and-materials work orders or based on accepted milestones for deliverable-based work orders, requiring mandatory written acceptance from TRS. All technical solutions must align with the TRS AI Governance Framework and meet WCAG 2.1 Level AA accessibility standards.
Teacher Retirement System of Texas

POSTED

3 days ago

DEADLINE

in 9 days
View Details

Prepare for this forecast

Research this forecast and prepare for the solicitation

Every page of the solicitation package shredded into a compliance breakdown

AI-powered matching based on your capabilities and past performance

Competitor and incumbent history on the requirement

Automated alerts on amendments, Q&A deadlines, and award

Miguel
Hillary
Keith Deutsch
Christine

Join 750+ contractors already using CLEATUS