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.
التثبيت
خطوات التثبيت موجودة في التوثيق أدناه. التوثيق
التوثيق
مأخوذ من ملف README للمشروع على GitHub ويُحدَّث أسبوعيًا. تفتح الروابط على GitHub.
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(legacyhttps://radar.healthai.com/api/mcpstill 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-Keyheader 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.
الأسئلة الشائعة
ما هو 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.
كيف أثبّت Fda Risk Radar MCP؟
اتبع خطوات التثبيت في توثيقه المعروض في هذه الصفحة وفي مستودعه.
هل Fda Risk Radar MCP مفتوح المصدر؟
نعم. شيفرته متاحة على GitHub بترخيص MIT.
من يصون Fda Risk Radar MCP؟
ينشره thehealthai. يدرجه AI.tn لكنه لا يصونه ولا يوصي به.
من القوائم المجتمعية awesome-mcp-servers ومستودع المشروع على GitHub. الإدراج ليس توصية: راجع شيفرة الخادم وصلاحياته قبل منحه الوصول إلى بياناتك.