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FDA 510(k) Compliance & Regulatory Submission Support

Active

Federal

Response Deadline08/13/2026, 08:00:00 PM UTC

Contract Overview

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

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This subcontract opportunity with the Department of Veterans Affairs, specifically the Commodities and Services Acquisition Service, focuses on providing expert regulatory consulting services. The primary objective is the preparation and submission of FDA 510(k) documentation to ensure medical devices meet necessary regulatory standards. Additionally, the contract requires ensuring full compliance with Buy American Act and Trade Agreements Act requirements for medical device procurement. The project is categorized under NAICS code 541690 and is designated for performance in the 80401 zip code area. Interested parties must note the tight turnaround for responses, with the solicitation posted on August 11, 2026, and a response deadline set for August 13, 2026.

General Info

VA subcontract for FDA 510(k) regulatory consulting services and medical device compliance.

Agency

Department Of Veterans Affairs → Commodities & Services Acquisition Service (36C791)View Agency

NAICS

541690 - Other Scientific and Technical Consulting ServicesView NAICS

Place of Performance

CO, 80401, USA

Set-Aside

NONE

Documents

This scope was carved out of 36C791-27-AP-0004.

The full solicitation package (1 document), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

FY26 Recompete of the Electro-Therapeutic Modalities for Pain Management (ETMPM) - Transcutaneous Electrical Nerve Stimulation (TENS) Procurement Program

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Timeline

PostedAug 11

subcontract

Response DeadlineAug 13

Submission deadline

Response Deadline

08/13/2026, 08:00:00 PM UTCin 1 day

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Organization & Contact Information

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AgencyDepartment Of Veterans Affairs → Commodities & Services Acquisition Service (36C791)

ContactsNo contacts available

OfficeN/A

Organization / Agency

Department Of Veterans Affairs → Commodities & Services Acquisition Service (36C791)

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Office AddressN/A

ContactsNo contact information available

Full Description

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Regulatory consulting for preparation and submission of FDA 510(k) documentation and compliance with BAA/TAA for medical device procurement.

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