FDA AI Search: Making FDA-Authorized AI Devices Searchable

• URL: http://arxiv.org/abs/2602.00006v1
• Date: Fri, 21 Nov 2025 20:21:08 GMT
• Title: FDA AI Search: Making FDA-Authorized AI Devices Searchable
• Abstract summary: Over 1,200 AI-enabled medical devices have received marketing authorization from the U.S. FDA.<n>The FDA's databases contain only limited metadata and non-searchable summary PDFs.<n>We develop FDA AI Search, a website that enables semantic querying of FDA-authorized AI-enabled devices.
• Score: 0.0
• License: http://creativecommons.org/licenses/by/4.0/
• Abstract: Over 1,200 AI-enabled medical devices have received marketing authorization from the U.S. FDA, yet identifying devices suited to specific clinical needs remains challenging because the FDA's databases contain only limited metadata and non-searchable summary PDFs. To address this gap, we developed FDA AI Search, a website that enables semantic querying of FDA-authorized AI-enabled devices. The backend includes an embedding-based retrieval system, where LLM-extracted features from authorization summaries are compared to user queries to find relevant matches. We present quantitative and qualitative evaluation that support the effectiveness of the retrieval algorithm compared to keyword-based methods. As FDA-authorized AI devices become increasingly prevalent and their use cases expand, we envision that the tool will assist healthcare providers in identifying devices aligned with their clinical needs and support developers in formulating novel AI applications.

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