SAM #75F40126Q00351

FDA Solicitation for Regulatory Science Tool for Transcranial Ultrasound Modeling

The U.S. Food and Drug Administration (FDA) Office of Science and Engineering Laboratories (OSEL), within the Center for Devices and Radiological Health (CDRH), is seeking a contractor to develop a Regulatory Science Tool for transcranial ultrasound (TUS) modeling. - Government Buyer: - Department of Health and Human Services (DHHS) - Food and Drug Administration (FDA) - Office of Science and Engineering Laboratories (OSEL), Center for Devices and Radiological Health (CDRH) - Products/Services Requested: - Regulatory Science Tool for Transcranial Ultrasound Modeling - Computational modeling package for simulating TUS sonication protocols - Includes acoustic and thermal modeling, validation datasets, tissue property mapping, sensitivity analysis, patient reference models, and comprehensive documentation - Contractor services for development, validation, and delivery of the tool - Technical evaluation, prototype development, multi-element array implementation, sensitivity analysis, validation, documentation, and dissemination support - Quantities: - 1 modeling package (product) - 1 service contract (development and delivery) - Unique/Notable Requirements: - Tool must standardize TUS simulation for device developers, researchers, and regulators - Must include validation datasets and tissue property databases - Patient reference models and comprehensive documentation required - Quarterly deliverables throughout a 12-month period - OEMs and Vendors: - No specific OEMs or vendors are named in the solicitation - The contract is a firm fixed price award for a 12-month period

Description

Regulatory Science Tool for Transcranial 1Ultrasound Modeling

see attached Solicitation

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