Search. Assess. Prepare. Submit.
The only free public platform that combines semantic search of every FDA-authorized AI medical device with live regulatory risk monitoring - recalls, adverse events, and warning letters - plus cybersecurity evidence analysis and IEC 62304 risk classification.
Beyond Search: Regulatory Intelligence
Every device includes cybersecurity evidence analysis, IEC 62304 risk classification, and submission readiness assessment.
Cybersecurity Evidence
SBOM presence, §524B compliance, and CVE management indicators for every device.
Powered by SBOMator™Evidence Requirements
IEC 62304 evidence requirements mapped by device risk class and regulatory pathway.
Parasoft expertiseRisk Classification
Automatic IEC 62304 Class A/B/C and FDA device class estimation for each AI device.
IEC 62304 expertSubmission Readiness
Interactive wizard identifies evidence gaps and connects you to ESL's scoping workshop.
Start assessment →Why This Platform Exists
ESL FDA AI Device Intelligence transforms FDA's opaque approval database into actionable intelligence for patients, clinicians, and device manufacturers - while positioning ESL as the go-to consultancy for FDA software evidence and regulatory remediation.
For the Public & Patients
Search every FDA-authorized AI device by what it does. See recalls, adverse events, and warning letters - live from FDA databases, free, no login.
For Device Companies
Competitive intelligence before you spend millions on a submission. See what pathway competitors used, what evidence they provided, and what regulatory concerns exist for comparable devices.
For ESL
Every search creates a qualified lead. Every regulatory concern links to ESL remediation. Every assessment connects to a scoping workshop. A public utility that drives consultancy engagement.
Search engine based on FDA AI Search by Kavishwar & Lotter (Dana-Farber / Harvard, ML4H 2025, CC BY 4.0). Regulatory-engineering layers by Engineering Software Lab. Learn what we added →