Request for Service: Pulse Field Ablation Comparative Assessment Development

The FDA's Center for Devices and Radiological Health seeks development of a comparative assessment for Pulse Field Ablation technology, including fabrication of PFA catheters and a hemolysis testing platform, with proposals due July 20 at 10:00 AM EST and questions due July 10. The procurement is set aside for small businesses (1,000-employee size standard) and is structured as a firm fixed price agreement under FAR Part 12 commercial item procedures.

Performance occurs at the contractor's facility. The scope requires fabrication of a minimum of 30 quality-controlled, reusable PFA catheters in two distinct electrode designs using gold or platinum iridium materials, with FDA design approval prior to fabrication; development of a robust comparative hemolysis benchtop test platform; and creation of a detailed standard operating procedure for hemolysis testing. The contractor must deliver 18 electrodes for FDA internal testing and quality control, with the remaining 12 unused electrodes and detailed protocols sent to FDA. All data and protocols are due by September 2027.

Required capabilities include demonstrated expertise in pulsed electric fields applied to biological tissue within BSL-2+ laboratory environments, access to animal or human blood within 48 hours of collection, and access to a spectrophotometer for plasma free hemoglobin measurement. Dedicated personnel must include a Principal Investigator and a full-time PhD student or Post-Doctoral researcher. The contractor must participate in bi-weekly FDA teleconferences and possess proficiency with a function generator capable of specific PFA waveform parameters.

The base year is 12 months with an optional 6-month extension. NAICS code is 541714 (Research and Development in Biotechnology); PSC is B529 (Special Studies/Analysis—Scientific Data). Evaluation prioritizes technical understanding of requirements and cost/price reasonableness, with award to the lowest-priced technically acceptable offeror. Proposals should be emailed to Telisha Wilson at telisha.wilson@fda.hhs.gov.