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Medical Product Cybersecurity and Software Development

Active

Federal

Response Deadline01/22/2027, 10:00:00 PM UTC

Contract Overview

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

AI Contract Overview

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This subcontract opportunity, titled Medical Product Cybersecurity and Software Development, is issued by the FDA Office of Acquisition and Grant Services under the Department of Health and Human Services. The project focuses on supporting prime contractors on FDA regulatory science initiatives by developing software tools and conducting comprehensive security audits for digital health applications and medical devices. Key technical requirements include performing penetration testing, establishing cybersecurity frameworks, and creating a Draft Security Plan to ensure the protection of sensitive data. The selected provider will be responsible for delivering operational software, source and executable code, and detailed vulnerability reports. Interested parties should note that the response deadline is January 22, 2027, and the work falls under NAICS code 541511 for custom computer programming services.

General Info

Agency

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

NAICS

541511 - Custom Computer Programming Services

Place of Performance

MD

Set-Aside

NONE

Documents

This scope was carved out of FDABAA-27-00123.

The full solicitation package (4 documents), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

FY27 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science

AI Contract Breakdown

Uniform Contract Format

No documents to break down

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

Timeline

PostedOct 30

subcontract

Response DeadlineJan 22

Submission deadline

Response Deadline

01/22/2027, 10:00:00 PM UTCin 3 months

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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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Develops software tools and performs security audits for medical devices and digital health applications for prime contractors on FDA regulatory science projects. Performs penetration testing and develops cybersecurity frameworks. Requires ability to produce a Draft Security Plan to protect sensitive data. Delivers source/executable code, vulnerability reports, and operational software.

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