Pulsed Field Ablation (PFA) System for Non-Clinical Research Use
Closed Pre-Solicitation Posted
- Solicitation number
- SSN_CDRH-2026-134633
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 334516 Analytical Laboratory Instrument Manufacturing
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The U.S. Food and Drug Administration is conducting market research through a Sources Sought Notice to identify qualified vendors capable of supplying one complete, off-the-shelf Pulsed Field Ablation (PFA) system for non-clinical research use, with responses due by August 10, 2026 at 10:30 a.m. ET. This notice is not a solicitation and does not commit the Government to issue one.
The required system must be FDA-approved or cleared for clinical use in the United States for treatment of atrial fibrillation or other cardiac arrhythmias and must include a PFA generator, five compatible clinical PFA catheters, accessories, cables, connectors, software, licenses, documentation, training, and technical support. The generator must produce a bipolar, biphasic pulsed electric field waveform and operate on standard 115-120 volt, 60 hertz single-phase power. All components must be new, unused, and current-production.
Delivery is FOB Destination to 10903 New Hampshire Avenue, Silver Spring, Maryland within 60 calendar days. The contractor must provide on-site installation, startup and operational verification, a minimum of one instructor-led training session within fifteen business days after acceptance, and manufacturer standard commercial warranty of not less than twelve months with telephone and email technical support.
The procurement applies to electromedical apparatus manufacturers under NAICS 334510. The notice seeks to determine domestic availability and whether sufficient small business sources exist to support a potential set-aside. Respondents must submit the native Microsoft Excel Vendor Response Form and a capability statement not exceeding ten pages in PDF format by email. Contact Contracting Officer Iris Johnson at (301) 796-3353 or Iris.Johnson1@FDA.hhs.gov.
Notice text
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.
Files
| File | Type | Posted |
|---|---|---|
| SOW_CDRH-2026-134633.pdf | ||
| SSN_CDRH-2026-134633.pdf |
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