thehealthai/fda-risk-radar-mcp

The MCP server behind **Constat** — FDA & NHTSA
regulatory-risk intelligence for AI agents, over the Model Context Protocol.
Live public regulatory data — recalls, adverse events, warning letters, 510(k)
premarket evidence, postmarket drift signals, reimbursement pathways, and
vehicle safety. **Decision support, not regulatory advice.**
- **Endpoint:** https://constat.dev/api/mcp (legacy https://radar.healthai.com/api/mcp still serves)
- **Transport:** Streamable HTTP (JSON-RPC 2.0)
- **Auth:** none for anonymous access (10 work units/min and 50/day per
anonymous source); an optional X-API-Key header enables the separately
assigned metered allowance. Tool calls have documented work-unit costs.
- **Registry:** com.healthai/radar (official MCP registry)
The evidence corpus and tool logic run hosted at the endpoint above. This repo
also ships server.mjs, a zero-dependency **stdio bridge** to that endpoint, so
stdio-only MCP clients can use the server like any local one:
Tools
| Tool | What it does |
|------|--------------|
| device_risk_lookup | FDA compliance risk for a device category by 3-letter product code — recalls, MAUDE trend, warning-letter matches, composite score |
| firm_compliance_history | Source-bounded FDA public-record timeline for a device firm — recalls, warning letters, 483s, clearances |
| watchlist_diff | Machine-detected FDA public-record changes for monitored product codes since a given date |
| device_evidence_lookup | Parsed 510(k) premarket evidence for an AI/ML device, each field with a verbatim source quote + page |
| evidence_search | Find AI/ML clearances by product code, panel, applicant, clinical data, sensitivity metric, or PCCP |
| predicate_chain | Trace a device's predicate ancestry with each predicate's age at clearance |
| evidence_cohort_stats | Reporting-rate stats across the parsed AI/ML corpus — presence figures with denominators |
| device_postmarket_lookup | Post-clearance intelligence for one device — recalls, MAUDE trend, letter/483 matches, drift signals |
| postmarket_search | Find devices by postmarket criteria — drift signals, recalls in 24mo, rising MAUDE trend |
| cohort_postmarket_stats | Postmarket presence rates across the AI/ML cohort, each with its denominator |
| reimbursement_lookup | Clearance-to-payment pathway by K/DEN or CPT code — NTAP, Cat I/III, CMS rates, HCPCS, LCDs |
| reimbursement_search | Find payment pathways by mechanism, CPT category, NTAP status, applicant |
| reimbursement_stats | Mechanism distribution across the reimbursement corpus with dollar ranges |
| vehicle_risk_lookup | NHTSA safety history by make/model/year — recall campaigns and complaint stats |
Quick start
List tools with {"method":"tools/list"}. Note the Accept header must include