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Cybersecurity & Digital Health Consultants

Active

Federal

Response Deadline11/17/2026, 07:00:00 PM UTC

Contract Overview

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

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The Cybersecurity and Digital Health Consultants subcontract, issued by the FDA Office of Acquisition and Grant Services under the Department of Health and Human Services, focuses on providing specialized technical consultations for prime contractors on CDRH projects. The scope of work involves performing cybersecurity consultations, digital health reviews, and AI/ML application analysis specifically for software-driven medical devices. To successfully execute these tasks, the contractor must possess deep expertise in Computer Science and Data Science to deliver comprehensive cybersecurity assessment reports and technical review documents. Performance will take place in Silver Spring, Maryland, and requires strict adherence to NIST SP 800-53 or NIST SP 800-171 standards for the handling of Controlled Unclassified Information. This opportunity falls under NAICS code 541512, with a response deadline set for November 17, 2026.

General Info

Agency

Department Of Health And Human Services → FDA Office Of Acq Grant Svcs

NAICS

541512 - Computer Systems Design Services

Place of Performance

Silver Spring, MD, 20993, USA

Set-Aside

NONE

Documents

This scope was carved out of 75F40127Q00006.

The full solicitation package (2 documents), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

FDA/CDRH Scientific Technical Capacity for Regulatory Review

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Timeline

PostedOct 30

subcontract

Response DeadlineNov 17

Submission deadline

Response Deadline

11/17/2026, 07:00:00 PM UTCin 18 days

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → FDA Office Of Acq Grant Svcs

ContactsNo contacts available

OfficeN/A

Organization / AgencyDepartment Of Health And Human Services → FDA Office Of Acq Grant Svcs

Office AddressN/A

ContactsNo contact information available

Full Description

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Provides technical consultations on security and digital integration for prime contractors on FDA CDRH projects. Performs cybersecurity consultations, digital health reviews, and AI/ML application analysis for software-driven medical devices. Requires expertise in Computer Science and Data Science. Must comply with NIST SP 800-53 or NIST SP 800-171 for CUI handling. Delivers cybersecurity assessment reports and technical review documents.

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