SAM #RFQ134632

FDA Seeks Contractor for Physiological Signal Dataset Development for AI/ML Wearable Device Research

The Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) is seeking a contractor to develop a comprehensive physiological signal dataset for AI/ML wearable device research. - Government Buyer: - Food and Drug Administration (FDA) - Center for Devices and Radiological Health (CDRH) - No specific OEMs or commercial vendors are named in the solicitation. - Services Requested: - Phase 1: Systematic review and synthesis of publicly available cardiac physiological signal datasets, with a peer-reviewed manuscript deliverable - Phase 2: Design and execution of a clinical study to collect synchronized physiological signals (ECG, PPG, accelerometry, blood pressure) from 50 healthy adults (25 male, 25 female) across four sessions - Includes dataset annotation, de-identification, and delivery in standard formats - Requires access to raw signals from multiple wearable devices - Collaboration with FDA subject matter experts (SMEs) - Option Year 1: Manuscript preparation, revision, publication support, and public dataset release package - Unique/Notable Requirements: - Data must be collected from multiple wearable devices and include raw signal access - Dataset must be annotated, de-identified, and prepared for public dissemination - Contractor must collaborate closely with FDA SMEs - Deliverables include both scientific manuscripts and a publicly releasable dataset - No products, part numbers, or specific commercial hardware are being procured; the focus is on research and dataset development services.

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Physiological Signal Dataset Development for AI/ML Wearable Device Research

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