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Medical Device Prototype Development and Engineering

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.

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The Medical Device Prototype Development and Engineering subcontract, issued by the FDA Office of Acquisition and Grant Services under the Department of Health and Human Services, focuses on the design and manufacture of hardware prototypes and medical devices for FDA regulatory science projects. The selected provider will be responsible for engineering design, rapid prototyping, and hardware integration, ensuring all work adheres to Good Manufacturing Practices where applicable. Key deliverables include physical prototypes, detailed engineering drawings, and comprehensive hardware performance specifications. This opportunity is categorized under NAICS code 334510 and was posted on October 30, 2026. Interested parties must submit their responses by the deadline of January 22, 2027. The contract is structured as a subcontract to support prime contractors in delivering critical hardware solutions for regulatory science initiatives.

General Info

Agency

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

NAICS

334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing

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

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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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Designs and manufactures hardware prototypes or medical devices for prime contractors on FDA regulatory science projects. Performs engineering design, rapid prototyping, and hardware integration. Requires compliance with Good Manufacturing Practices (GMP) where applicable. Delivers physical prototypes, engineering drawings, and hardware performance specifications.

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