Fda risk radar MCP agent

Constat — 483 Risk Radar (MCP server)

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:

node server.mjs            # stdio MCP server, bridges to constat.dev/api/mcp

// e.g. in an MCP client config
{ "mcpServers": { "constat": { "command": "node", "args": ["/path/to/server.mjs"] } } }

docker build -t constat-mcp . && docker run -i constat-mcp   # same, containerized

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

curl -s https://constat.dev/api/mcp \
  -H 'content-type: application/json' \
  -H 'accept: application/json, text/event-stream' \
  -d '{"jsonrpc":"2.0","id":1,"method":"tools/call",
       "params":{"name":"device_risk_lookup","arguments":{"product_code":"FRN"}}}'

List tools with {"method":"tools/list"}. Note the Accept header must include text/event-stream (streamable-HTTP requirement).

Each of the 14 tools declares an output schema. Tool calls return structured content with an explicit ok, not_found, invalid_request, or unavailable status while preserving a text result for older clients.

The tools are observational and non-destructive, but advertise readOnlyHint: false because calls write bounded quota and operational- telemetry state. They do not publish or modify FDA, CMS, NHTSA, or other third-party records.

See the integration guide, architecture and trust boundaries, privacy notice, and support page.

Related servers

• Clarity MCP — condition-aware ingredient, product & supplement safety (verdict + evidence tier + citation).
• MCP Queen — the graded MCP registry that independently probes and grades this server.

About

Built by Health AI, the team behind Constat. Informational only; verify against primary FDA/NHTSA sources.

License

MIT — see LICENSE.