Pulsed Field Ablation System (PFA)

The FDA's Center for Devices and Radiological Health seeks one complete, off-the-shelf Pulsed Field Ablation system for non-clinical research use, with offers due September 3 and questions due August 27. This is a commercial item acquisition under FAR Part 12 with no small business set-aside.

Delivery must be completed within 30 calendar days of order receipt to 10903 New Hampshire Avenue, Silver Spring, MD 20993, FOB Destination. The system must be FDA-approved or cleared for clinical use in treating atrial fibrillation or other cardiac arrhythmias and must be new, unused, current production equipment. The complete package includes a PFA generator, five compatible clinical PFA catheters, all accessories, cables, connectors, applicable software and licenses, setup and startup assistance, functional testing, manufacturer's standard warranty for a minimum of twelve months from government acceptance, and technical support by telephone and email during the warranty period. The system must be compatible with standard building power (115–120 volts, 60 hertz, single phase) and may be either cart-mounted or tabletop. Training must include a minimum of one instructor-led session (in person or virtual) within fifteen business days of delivery covering system components, operation, safety, troubleshooting, and maintenance. On-site activities are restricted to Monday–Friday, 6:30 a.m.–3:00 p.m. ET, excluding Federal holidays and facility closures.

The NAICS code is 334510 (Electromedical and Electrotherapeutic Apparatus Manufacturing); PSC is 6515. Evaluation uses Lowest Price Technically Acceptable with technical acceptability determined on a pass/fail basis and price evaluated for reasonableness. Quotations must be submitted via email in two volumes: technical (excluding pricing) and pricing. Quotation validity must be at least 90 days from the RFQ due date. Contact Contracting Officer Iris Johnson at Iris.Johnson1@FDA.hhs.gov or (301) 796-3353.