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Regulatory Strategy and FDA Submission Support

Active

Federal

Response Deadline08/12/2026, 04:00:00 PM UTC

Contract Overview

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

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This contract involves providing specialized regulatory consulting and support services for FDA Center for Devices and Radiological Health (CDRH) submissions related to neuromodulation devices. The scope includes assistance with 510(k) and De Novo regulatory pathways, as well as the preparation and review of design control documentation essential for compliance with FDA requirements. The contract is categorized under NAICS code 541611, indicating management consulting services. Issued by the Advanced Research Projects Agency for Health (ARPA-H), under the Department of Health and Human Services, the opportunity is a subcontract arrangement. The solicitation was posted on June 16, 2026, with responses due by August 12, 2026. While specific geographic details for performance and organizational types are not provided, the contract emphasizes critical support to facilitate FDA approval processes for innovative neuromodulation technologies, underscoring the importance of regulatory expertise in medical device development within a government research framework.

General Info

Provide regulatory consulting for FDA neuromodulation device submissions, supporting 510(k) and De Novo pathways.

Agency

Department Of Health And Human Services → Advanced Research Projects Agency For Health (arpa-H)View Agency

NAICS

541611 - Administrative Management and General Management Consulting ServicesView NAICS

Place of Performance

DC

Set-Aside

NONE

Documents

(0)

No documents available

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Timeline

PostedJun 16

subcontract

Response DeadlineAug 12

Submission deadline

Response Deadline

08/12/2026, 04:00:00 PM UTCin 17 days

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → Advanced Research Projects Agency For Health (arpa-H)

ContactsNo contacts available

OfficeN/A

Organization / Agency

Department Of Health And Human Services → Advanced Research Projects Agency For Health (arpa-H)

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Office AddressN/A

ContactsNo contact information available

Full Description

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Provide regulatory consulting and support for FDA CDRH submissions of neuromodulation devices, including 510(k)/De Novo pathways and design control documentation.

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