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Pulsed Field Ablation (PFA) System for Non-Clinical Research Use

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SSN_CDRH-2026-134633Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

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The U.S. Food and Drug Administration is seeking information from vendors capable of providing a complete, off-the-shelf Pulsed Field Ablation (PFA) system intended for non-clinical research use. The required system must include a PFA generator, compatible catheters, all necessary accessories and cables, on-site installation, startup and operational verification, training, comprehensive documentation, warranty coverage, and ongoing technical support. The system must be FDA-approved or cleared for clinical use in the United States to treat atrial fibrillation or other cardiac arrhythmias, ensuring its technological validity and regulatory compliance. This request is solely for market research and does not obligate the government to proceed with a procurement or issue a formal solicitation. Vendors interested in responding must submit the required Vendor Response Form along with supporting documentation demonstrating their capability to meet all specified requirements by the deadline of August 10, 2026, at 2:30 PM Eastern Time. The solicitation number is SSN_CDRH-2026-134633, and the NAICS code is 334516. All responses should be directed to Iris Johnson at the FDA Office of Acquisition and Grant Services in Rockville, Maryland, with contact information provided for email and phone. This sources sought notice is posted on SAM.gov and is part of the FDA’s effort to evaluate available commercial solutions before potential future procurement actions.

General Info

FDA seeks off-the-shelf PFA systems for non-clinical research with full support and FDA clearance.

Agency

Department Of Health And Human Services → FDA Office Of Acq Grant SvcsView Agency

NAICS

334516 - Analytical Laboratory Instrument ManufacturingView NAICS

Place of Performance

MD

Set-Aside

NONE

Documents

(2)

SOW_CDRH-2026-134633.pdf

PDF

SSN_CDRH-2026-134633.pdf

PDF

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Timeline

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → FDA Office Of Acq Grant Svcs
Contacts1 person available
OfficeRockville, MD, 20852, USA
Organization / Agency
Department Of Health And Human Services → FDA Office Of Acq Grant Svcs
View Agency Profile
Office AddressRockville, MD, 20852, USA
Contacts
Iris Johnson
contact@example.gov
+1 (555) 000-0000

Full Description

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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.

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New
Federal
Custom Multi-Component Veterinary Drug Reference Standards (Macrolides)The contract involves the production of ISO 17034-certified reference standards for macrolide antibiotics, specifically including Virginiamycin M1, to be delivered in two certified lots designated as ICV and CCV. Each lot will consist of five 1mL glass ampules, prepared under strict quality control to ensure purity, stability, and consistency suitable for use in LC-MS method calibration within veterinary drug testing. Full traceability of materials, processes, and analytical data is required, with each ampule accompanied by a detailed Certificate of Analysis that verifies identity, concentration, homogeneity, and stability under specified conditions. The standards must comply with international metrological requirements to support reliable analytical results in regulatory and diagnostic labs. The work is solicited as a subcontract under the Department of Health and Human Services, specifically managed by the FDA Office of Acquisition and Grant Services, with performance based in Denver, Colorado, 80225. The solicitation was posted on August 4, 2026, and responses are due by August 7, 2026, indicating a tight turnaround for technical proposal submission. The NAICS code 325412 classifies this as pharmaceutical and medicine manufacturing, underscoring the need for specialized expertise in reference material production. Deliverables must meet the highest regulatory benchmarks for certification, ensuring that the reference materials are fit for use in compliance testing, quality assurance, and method validation across veterinary drug monitoring programs.
Pharmaceutical Preparation Manufacturing

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NAICS: 325414
New
Federal
Custom Multi-Component Veterinary Drug Reference Standards (NSAIDs)The contract entails the manufacture and delivery of ISO 17034-certified analytical reference standards specifically for nonsteroidal anti-inflammatory drugs (NSAIDs) to support veterinary drug residue testing. Two certified lots—intermediate control verification (ICV) and candidate control verification (CCV)—will be produced, each containing five 1mL glass ampules sealed for stability and purity. The reference standards are to be dissolved in LC-MS grade solvents to ensure compatibility with high-performance liquid chromatography and mass spectrometry workflows. All materials must meet rigorous certification standards to guarantee accuracy, traceability, and consistency in quantitative analytical applications. The work is required to be completed under a subcontract with a response deadline of August 7, 2026, and the place of performance is designated as Denver, Colorado, with a zip code of 80225. The contracting entity is the FDA Office of Acquisition and Grant Services under the Department of Health and Human Services, operating under NAICS code 325414, which corresponds to pharmaceutical preparation manufacturing. The deliverables are critical for laboratory quality control and regulatory compliance in animal health testing, requiring strict adherence to certification protocols and documentation without compromising sample integrity or analytical validity.
Biological Product (except Diagnostic) Manufacturing

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