This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in FAR 12.6 as supplemented with FAR 13 and additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2022-04. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION. A SEPARATE SOLICITATION DOCUMENT ( I.E. STANDARD FORM ) WILL NOT BE ISSUED. The solicitation number for this acquisition is RFQ-FDA-75F40122Q00059 and is being issued as a Request for Quote (RFQ). The NAICS Code for this solicitation: 334516 Analytical Laboratory Instrument Manufacturing. The Small Business Size Standard is 1,000 employees. This is a 100% small business set-aside. Simplified acquisition procedures will be utilized. The U.S. Food & Drug Administration (FDA), Office of Acquisitions and Grant Services (OAGS) requires one (1) Whole Blood Platelet Aggregometer in accordance with the requirements identified herein. Inquires Offerors must submit all questions concerning this solicitation in writing electronically to
[email protected]. Questions must be received no later than April 15, 2022 4:00 p.m. Eastern Standard Time. Any responses to questions will be made in writing, without identification of the questioner, and will be included in an amendment to the solicitation. Even if provided in other form, only the question responses included in the amendment to the solicitation will govern performance of the contract. BACKGROUND INFORMATION The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable, and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health. The mission of the Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. CDRH assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. CDRH provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products CDRH oversee. CDRH facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S. The Office of Science and Engineering Laboratories (OSEL) supports the CDRH’s mission of protecting and promoting public health. The OSEL undertakes the highest quality science to provide their customers with the best methods, tools and expertise to: Ensure readiness for emerging and innovative medical technologies Develop appropriate evaluation strategies and testing standards Create accessible and understandable public health information and Deliver timely and accurate decisions for products across their life cycle. Under the OSEL, the Division of Applied Mechanics (DAM) participates in the Center's mission of protecting and promoting public health by identifying and using applied mechanics to investigate interactions between medical devices and the human body. The DAM specifically focuses on device issues that involve additive manufacturing, biologically relevant parameters for device and materials, blood damage, computational modeling, device and material mechanical integrity device-fluid interactions, materials durability, transport of heat, drugs, biological pathogens, ultrasound power measurements, phantoms and dosimetry. In collaboration with the OSEL, the DAM requires a Whole Blood Platelet Aggregometer for characterizing platelet quality and aggregation properties in whole blood and platelet-rich-plasma (PRP). This equipment will be used in the DAM research projects to develop and improve blood compatibility test methods for medical devices and materials. This equipment will allow the DAM to measure and compare blood coagulation properties in human and different animal species under different test conditions. Whole blood aggregation has two major advantages, first the technique evaluates platelets in the presence of red and white blood cells, which are known to modulate platelet function and second, it eliminates the need for whole blood centrifugation, thus avoiding injury to platelets and loss of giant thrombocytes. On the other hand, platelet aggregation in PRP has been historically considered as a standard method for platelet function analysis. An instrument with both whole blood and PRP aggregation functions will enable the DAM to compare the results between these two methods, which is important for the DAM’s research program that aims to develop and improve various blood compatibility test methods. NOTE: Reference attachment titled, "RFQ-FDA-75F40122Q00059," for complete combined synopsis/solicitation.