Opportunity
SAM #75F40126Q00391
FDA Solicitation for Pulsed Field Ablation (PFA) System for Non-Clinical Research
Buyer
FDA Office of the Associate General Counsel for Administrative Law
Posted
August 25, 2026
Respond By
September 03, 2026
Identifier
75F40126Q00391
NAICS
334510, 339112, 541715, 423490
The U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), is seeking to procure a complete Pulsed Field Ablation (PFA) system for non-clinical cardiac ablation research. - Government Buyer: - U.S. Food and Drug Administration (FDA) - Center for Devices and Radiological Health (CDRH) - OEMs and Vendors: - No specific OEMs or vendors are named in the solicitation - Products/Services Requested: - One complete, off-the-shelf Pulsed Field Ablation (PFA) system - Includes PFA generator - Five compatible clinical PFA catheters (same model/configuration; expired catheters acceptable for research) - All necessary accessories, cables, connectors, adapters - Required software and licenses - Documentation - Setup/startup assistance - Functional testing - Training for approximately 4-5 FDA users - Minimum 12-month warranty - Technical support - Unique or Notable Requirements: - System must be FDA-approved or cleared for clinical use in the U.S. - All components must be new, off-the-shelf, and suitable for research lab use - Delivery required within 30 days of order; training within 15 business days after delivery and before acceptance - Expired catheters are acceptable for non-clinical research - Post-warranty support is optional and not included unless separately ordered
Description
The U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), has a requirement for one complete, off-the-shelf Pulsed Field Ablation (PFA) system for use in a non-clinical research environment. The required system includes a PFA generator, five compatible clinical PFA catheters, all required accessories, cables, connectors, applicable software and licenses, setup/startup assistance, functional testing, training, warranty coverage, and technical support, in accordance with Attachment 1 – Statement of Work (SOW).
Questions are due Thursday, August 27, 2026, at 10:30 a.m. ET.
Offers are due Thursday, September 3, 2026, at 2:30 p.m. ET.