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This Government Contract opportunity from Department Of Health And Human Services was posted on August 25, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

PFA Generator and Durable Accessories Supply

Closed
Federal

Contract Overview

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

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NAICS: 334510
New
Grant
NextTech: Translational Development of Next-Generation Diagnostic and Therapeutic Devices (R18 Clinical Trial Not Allowed)
Solicitation # RFA-EB-28-004
The National Institutes of Health (NIH) is soliciting applications under RFA-EB-28-004 for the NextTech program to advance the development and translation of next-generation diagnostic and therapeutic devices. This initiative supports technologies designed to prevent, monitor, diagnose, and treat disorders aligned with the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) and Helping to End Addiction Long-term (HEAL) missions. The primary goal is to move new devices toward readiness for first-in-human clinical trials by focusing on technology optimization and regulatory preparation rather than basic biological research. The program has a total funding pool of 6,000,000 dollars, with an intent to fund approximately 4 to 12 awards, typically limiting direct costs to 750,000 dollars per year. Awards are determined through a two-stage process involving scientific peer review and a second-level review by the National Advisory Council for Biomedical Imaging and Bioengineering. Evaluation is based on scientific and technical merit, relevance to program priorities, and the specific advantage the device offers over existing clinical approaches. Applicants must provide a detailed Gantt chart, a needs assessment with quantifiable metrics, a data management and sharing plan, and a reasonable regulatory path to market. Eligible applicants include for-profit organizations and small businesses, provided they maintain active SAM.gov and eRA Commons registrations. Foreign subawards are prohibited. Awardees must also adhere to strict cybersecurity requirements, including the development of an incident response plan and a 48-hour notification window for security breaches.
National Institutes Of Health

POSTED

3 days ago

DEADLINE

in about 4 years

AI Contract Overview

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The Department of Health and Human Services, through the FDA Office of Acquisition and Grant Services, is seeking a subcontract for the supply of a current-production Pulsed Field Ablation generator system. This procurement includes all necessary durable accessories, cables, connectors, adapters, and the required software licenses specifically for non-clinical research purposes. The opportunity is categorized under NAICS code 334510 and was posted on August 25, 2026. Interested parties must submit their responses by the deadline of September 3, 2026, at 6:30 PM.

General Info

FDA seeks subcontract for Pulsed Field Ablation generator system for non-clinical research.

NAICS

334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing

Place of Performance

MD

Set-Aside

NONE

Documents

This scope was carved out of 75F40126Q00391.

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

View the prime solicitation

Pulsed Field Ablation System (PFA)

AI Contract Breakdown

Uniform Contract Format

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

Timeline

PhaseClosed
Posted

subcontract

Response Deadline

Deadline has passed

Submission Closed

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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
Office AddressN/A
ContactsNo contact information available

Full Description

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Supply of a complete, current-production Pulsed Field Ablation (PFA) generator system, including durable accessories, cables, connectors, adapters, and required software/licenses for non-clinical research use.

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

Same awarding agency

NAICS: 541611
Federal
Contractor-Hosted Fully Integrated Records Facility (FIRF) IDIQ
Solicitation # 75F40126R00009
Solicitation 75F40126R00009 is a request for proposals for a single Indefinite Delivery, Indefinite Quantity (IDIQ) contract to provide Contractor-Hosted Fully Integrated Records Facility (FIRF) services for the FDA. This acquisition is exclusively set aside for Service-Disabled Veteran-Owned Small Business (SDVOSB) concerns under NAICS code 541611. The contract features a five-year ordering period from December 1, 2026, through November 30, 2031, with an additional six-month option to extend services. The IDIQ has a maximum ceiling of 50 million dollars and a guaranteed minimum of 10,000 dollars. Task orders may be issued as Time-and-Materials, Labor-Hour, Firm-Fixed Price, or a combination thereof. The scope of work involves providing personnel, materials, and facilities for offsite document control services, with a strategic goal of transitioning to a near 100 percent electronic environment for premarket and postmarket submissions. Key responsibilities include program management, document processing, data and stakeholder support, and records management. Award will be made on a Lowest Price-Technically Acceptable (LPTA) basis, with technical factors and past performance evaluated as acceptable or unacceptable. Proposals are due by 2:00 PM Eastern Time on October 29, 2026, and must be submitted in three separate volumes, strictly adhering to formatting and file type restrictions to avoid being deemed non-responsive.
Administrative Management and General Management Consulting Services

POSTED

7 days ago

DEADLINE

in 3 days
View Details

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