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Terms of Use

Last updated: August 30, 2026

1. Acceptance of Terms

By accessing or using ESL FDA AI Device Intelligence (https://esl-fda.io), you agree to these Terms of Use. If you do not agree, please do not use the platform. These terms constitute a legally binding agreement between you and ESL Engineering Software Lab Ltd.

2. What This Platform Is

ESL FDA AI Device Intelligence is a free public web platform that provides semantic search across FDA-authorized AI medical devices, regulatory risk monitoring (recalls, adverse events, warning letters) from public FDA data, cybersecurity evidence analysis (SBOM and xBOM indicators), IEC 62304 risk class estimation, and submission readiness self-assessment.

3. No Medical or Regulatory Advice

This platform is an assistive research tool. It does NOT provide:

  • Medical advice, diagnosis, or treatment recommendations
  • Legal advice or regulatory counsel
  • FDA approval, clearance, or endorsement
  • A substitute for professional regulatory affairs consultation

The manufacturer retains full responsibility for the safety, effectiveness, and regulatory compliance of their device. Any decisions based on information from this platform should be verified against official FDA sources and reviewed with qualified regulatory professionals.

4. Data Accuracy and Limitations

While we strive for accuracy, the platform has inherent limitations:

  • Device data is sourced from FDA public AI device list and may not reflect the most recent updates
  • Cybersecurity evidence analysis is based on AI-generated device summaries or FDA Summary PDFs, not the complete submission package
  • Regulatory concerns are fetched in real time from public FDA APIs and may have delays
  • IEC 62304 risk classification is an ESL estimate, not an official FDA classification
  • The platform may make errors. Always verify critical information against primary sources

5. Acceptable Use

You agree NOT to:

  • Use the platform for any unlawful purpose
  • Attempt to overload, crash, or disrupt the platform or its APIs
  • Scrape, crawl, or extract data at automated rates that degrade service for others
  • Misrepresent the platform output as official FDA determinations
  • Use the platform to make medical decisions without consulting a healthcare professional
  • Reverse engineer, decompile, or attempt to access the platform source code or infrastructure

Reasonable automated access for research purposes is permitted. If you need bulk data access, contact us at sales@eswlab.com to discuss an API arrangement.

6. Intellectual Property

The platform source code is based on the open-source FDA AI Search project by Kavishwar & Lotter (Dana-Farber / Harvard, ML4H 2025, CC BY 4.0). ESL enhancements including the regulatory risk monitoring, cybersecurity evidence analysis, xBOM detection, IEC 62304 classification, and assessment wizard are proprietary to ESL. Device data displayed on the platform is sourced from public FDA databases and is in the public domain.

7. Disclaimer of Warranties

The platform is provided AS IS and AS AVAILABLE without warranties of any kind, either express or implied, including but not limited to accuracy, completeness, timeliness, merchantability, or fitness for a particular purpose.

8. Limitation of Liability

To the maximum extent permitted by law, ESL shall not be liable for any indirect, incidental, special, consequential, or punitive damages arising from your use of (or inability to use) the platform. You acknowledge that the platform is a free service.

9. Third-Party Links

The platform contains links to external sites (FDA.gov, Parasoft, eswlab.com). ESL is not responsible for the content, accuracy, or practices of these third-party sites.

10. No FDA Endorsement

ESL FDA AI Device Intelligence is not affiliated with, endorsed by, or sponsored by the U.S. Food and Drug Administration. FDA is used descriptively to refer to the public data and regulations administered by the agency.

11. Changes to These Terms

We may revise these Terms of Use at any time. Your continued use of the platform after changes constitutes acceptance of the revised terms.

12. Governing Law

These terms shall be governed by and construed in accordance with the laws of the State of Israel. Any disputes shall be resolved in the competent courts of Tel Aviv, Israel.

13. Contact

Questions about these Terms of Use? Contact us: