fdanhtsaregulatorymedical-devicesrisk
MCP server providing FDA and NHTSA regulatory risk intelligence and device compliance data via 14 specialized tools.
Quick Install
Automated & IDE SetupCopy the AI prompt to install this server into Claude Code, Cursor, or another agent — or use 1-click editor setup below.
Manual Client & Custom JSON ConfigExpand JSON ▾
Client Config & Setup
Remote HTTPChoose your client or environment
Target File:
💡 Paste the JSON block into your client's configuration file under mcpServers, then restart the application.
Overview
Use cases
Lookup FDA compliance risk by device product code
Retrieve FDA public-record compliance history for device firms
Search parsed 510(k) premarket evidence for AI/ML devices
Trace predicate device ancestry chains with clearance ages
Access NHTSA vehicle safety recall and complaint data
Key features
14 distinct tools for regulatory risk and compliance data
Streamable HTTP JSON-RPC 2.0 interface with event-stream support
No authentication required for limited anonymous access
Optional API key for metered usage
Includes device risk scores, postmarket drift signals, and reimbursement pathways
Provides verbatim source quotes and page references for evidence
Capabilities & Tool Schemas (14)
Inspect callable tools, capabilities, and parameters exposed to AI agents by Fda Risk Radar MCP.
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
Documentation Overview
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:
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
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.
Related MCP Servers
Adoption & maintenance
Factual signals from GitHub, npm, and our automated checks — not a rating.
Last commit
8d ago
Most recent push to the default branch.
Tools exposed
14
Callable tools this server registers over MCP.
Directory activity
2 views
Config copies, upvotes, and views on AllMCPs.
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Frequently Asked Questions about Fda Risk Radar MCP
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CategoryFinance & Fintech
PricingFreemium
59Quality signal: Good · 59/100How this signal is calculated ▾
Server availabilityNot measured
Not scored for repo-hosted servers — we can't reach the running server, only its GitHub page. Hosted MCP endpoints are health-checked live.
Verified ownership10/20
Documentation & tools30/30
Adoption & activity4/15
Community engagement0/10
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