SAM #SB134042

FDA Seeks Small Business Partner for Pulsed Field Ablation Catheter Fabrication and Hemolysis Test Platform Development

The FDA's Center for Devices and Radiological Health (CDRH), Office of Science and Engineering Laboratories (OSEL), Division of Applied Mechanics (DAM) is seeking a small business partner for a specialized research and development project: - Government Buyer: - U.S. Food and Drug Administration (FDA) - Center for Devices and Radiological Health (CDRH) - Office of Science and Engineering Laboratories (OSEL), Division of Applied Mechanics (DAM) - Products and Services Requested: - Fabrication of 30 reusable Pulsed Field Ablation (PFA) catheters - Two distinct electrode designs (15 catheters each) - Catheters must be constructed from gold or platinum iridium - Must be compatible with FDA's EPULSUS-FBMI-5 pulse generator - Includes detailed setup instructions - Development of an in vitro benchtop test platform to assess hemolytic potential of PFA devices - Includes quality control testing, static blood testing, and creation of detailed protocols and SOPs - Unique or Notable Requirements: - Contractor must have expertise in PFA research - Access to a BSL-2 laboratory, blood samples, and a spectrophotometer is required - All deliverables (catheters, protocols, data, SOPs) are due within one year of award - No specific OEMs or commercial vendors are named in the solicitation - The project is targeted at small businesses with relevant technical capabilities

Description

Request for Service: Pulse Field Ablation Comparative Assessment Development

Questions are due by 10AM EST on or before 07/10/2026

Proposals are due by 10AM EST on or before 07/20/2026

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