This Sources Sought opportunity from Department Of Health And Human Services was posted on August 5, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

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Pulsed Field Ablation (PFA) System for Non-Clinical Research Use

Closed

SSN_CDRH-2026-134633Federal

Submission Closed08/10/2026, 02:30:00 PM UTC

Contract Overview

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

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NAICS: 334516

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Solicitation # W911S227U0057

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POSTED

1 day ago

DEADLINE

in 24 days

AI Contract Overview

The U.S. Food and Drug Administration is seeking information from vendors capable of providing a complete, off-the-shelf Pulsed Field Ablation (PFA) system intended for non-clinical research use. The required system must include a PFA generator, compatible catheters, all necessary accessories and cables, on-site installation, startup and operational verification, training, comprehensive documentation, warranty coverage, and ongoing technical support. The system must be FDA-approved or cleared for clinical use in the United States to treat atrial fibrillation or other cardiac arrhythmias, ensuring its technological validity and regulatory compliance. This request is solely for market research and does not obligate the government to proceed with a procurement or issue a formal solicitation. Vendors interested in responding must submit the required Vendor Response Form along with supporting documentation demonstrating their capability to meet all specified requirements by the deadline of August 10, 2026, at 2:30 PM Eastern Time. The solicitation number is SSN_CDRH-2026-134633, and the NAICS code is 334516. All responses should be directed to Iris Johnson at the FDA Office of Acquisition and Grant Services in Rockville, Maryland, with contact information provided for email and phone. This sources sought notice is posted on SAM.gov and is part of the FDA’s effort to evaluate available commercial solutions before potential future procurement actions.

General Info

FDA seeks off-the-shelf PFA systems for non-clinical research with full support and FDA clearance.

Agency

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

NAICS

334516 - Analytical Laboratory Instrument Manufacturing

Place of Performance

Set-Aside

NONE

Documents

Sources Sought Notice SSN_CDRH-2026-134633 for Pulsed Field Ablation System

sources-sought

High

SOW for Pulsed Field Ablation System CDRH-2026-134633

sow

High

AI Contract Breakdown

Uniform Contract Format

Timeline

PhaseClosed

PostedAug 5

Sources Sought

Response DeadlineAug 10

Deadline has passed

Submission Closed

08/10/2026, 02:30:00 PM UTC

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Organization & Contact Information

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

Contacts1 person available

OfficeRockville, MD, 20852, USA

Organization / AgencyDepartment Of Health And Human Services → FDA Office Of Acq Grant Svcs

Office AddressRockville, MD, 20852, USA

Contacts

Iris Johnson

contact@example.gov

+1 (555) 000-0000

Full Description

The U.S. Food and Drug Administration is issuing this Sources Sought Notice for market research purposes to identify qualified sources capable of providing a complete, off-the-shelf Pulsed Field Ablation (PFA) system for non-clinical research use. The required system includes a PFA generator, compatible catheters, all necessary accessories and cables, on-site installation, startup and operational verification, training, documentation, warranty coverage, and technical support. The proposed system must be FDA-approved or cleared for clinical use in the United States for the treatment of atrial fibrillation or other cardiac arrhythmias.

This notice is not a solicitation and does not constitute a commitment by the Government to issue a solicitation or make an award. Interested vendors should review the attached Sources Sought Notice and submit the required Vendor Response Form and supporting capability information by the response deadline stated in the posting.