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Fda Risk Radar MCP

Community Security

FDA and NHTSA regulatory risk data: device compliance risk, 510(k) evidence, predicate chains, postmarket signals, reimbursement pathways and vehicle safety.

Source code Documentation

Install

The installation steps are in the documentation below. Documentation

Documentation

From the project's README on GitHub, refreshed weekly. Links open on GitHub.

Contents
  1. Constat — 483 Risk Radar (MCP server)
  2. Tools
  3. Quick start
  4. Related servers
  5. About
  6. License

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

ToolWhat it does
device_risk_lookupFDA compliance risk for a device category by 3-letter product code — recalls, MAUDE trend, warning-letter matches, composite score
firm_compliance_historySource-bounded FDA public-record timeline for a device firm — recalls, warning letters, 483s, clearances
watchlist_diffMachine-detected FDA public-record changes for monitored product codes since a given date
device_evidence_lookupParsed 510(k) premarket evidence for an AI/ML device, each field with a verbatim source quote + page
evidence_searchFind AI/ML clearances by product code, panel, applicant, clinical data, sensitivity metric, or PCCP
predicate_chainTrace a device's predicate ancestry with each predicate's age at clearance
evidence_cohort_statsReporting-rate stats across the parsed AI/ML corpus — presence figures with denominators
device_postmarket_lookupPost-clearance intelligence for one device — recalls, MAUDE trend, letter/483 matches, drift signals
postmarket_searchFind devices by postmarket criteria — drift signals, recalls in 24mo, rising MAUDE trend
cohort_postmarket_statsPostmarket presence rates across the AI/ML cohort, each with its denominator
reimbursement_lookupClearance-to-payment pathway by K/DEN or CPT code — NTAP, Cat I/III, CMS rates, HCPCS, LCDs
reimbursement_searchFind payment pathways by mechanism, CPT category, NTAP status, applicant
reimbursement_statsMechanism distribution across the reimbursement corpus with dollar ranges
vehicle_risk_lookupNHTSA 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.

  • 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.

Frequently asked questions

What is Fda Risk Radar MCP?

FDA and NHTSA regulatory risk data: device compliance risk, 510(k) evidence, predicate chains, postmarket signals, reimbursement pathways and vehicle safety.

How do I install Fda Risk Radar MCP?

Follow the installation steps in its documentation, shown on this page and in its repository.

Is Fda Risk Radar MCP open source?

Yes. Its code is on GitHub under the MIT license.

Who maintains Fda Risk Radar MCP?

It is published by thehealthai. AI.tn lists it but does not maintain or endorse it.

From the community awesome-mcp-servers lists and the project's GitHub repository. Listing is not an endorsement: review a server's code and permissions before giving it access to your data.