SAM #SSN_CDRH-2026-134633

FDA Solicits Complete Pulsed Field Ablation (PFA) System for Cardiac Research

The U.S. Food and Drug Administration (FDA) is seeking sources for a complete Pulsed Field Ablation (PFA) system for non-clinical cardiac ablation research. - Government Buyer: - U.S. Food and Drug Administration (FDA) - Office of Acquisitions and Grants Services (OAGS) - Products Requested: - One complete, off-the-shelf Pulsed Field Ablation (PFA) system - Must include: PFA generator, five compatible clinical PFA catheters (unused, unopened), all necessary accessories, cables, connectors, software, and licenses - System must be FDA-approved or cleared for clinical use in the U.S. for treatment of atrial fibrillation or other cardiac arrhythmias - Must be new and suitable for non-clinical research environments - Services Requested: - On-site installation, assembly, configuration, and operational verification - At least one instructor-led training session (in-person or virtual) for 3-4 end-users, covering setup, operation, safety, troubleshooting, cleaning, storage, and technical support - Provision of all documentation - Manufacturer's standard commercial warranty (minimum 12 months) including technical support, troubleshooting, repair or replacement - Unique/Notable Requirements: - Delivery required within 60 days after order - Training must be completed within 15 business days after acceptance - Detailed regulatory compliance and safety data must be provided - Warranty and technical support must be available for at least 12 months - No specific OEMs or vendors are named in the solicitation, but the system must be FDA-approved for clinical use in the U.S.

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.

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