Fda Risk Radar Mcp

thehealthai

The MCP server behind Constat: FDA & NHTSA regulatory-risk intelligence for agents — device compliance risk by 3-letter product code, parsed 510(k) premarket evidence with verbatim source quotes, predicate chains, postmarket drift signals, clearance-to-payment reimbursement pathways (NTAP/CPT/CMS), and NHTSA vehicle safety. 14 tools. Decision support, not regulatory advice. Hosted at constat.dev/api/mcp.

Quick Install

Automated & IDE Setup

Copy the AI prompt to install this server into Claude Code, Cursor, or another agent — or use 1-click editor setup below.

Add to Cursor Add to VS Code

Manual Client & Custom JSON ConfigExpand JSON ▾

Install Config Generator

claude_desktop_config.json

{
  "mcpServers": {
    "thehealthai-fda-risk-radar-mcp": {
      "command": "npx",
      "args": [
        "-y",
        "thehealthai-fda-risk-radar-mcp"
      ]
    }
  }
}

💡 Paste into ~/Library/Application Support/Claude/claude_desktop_config.json (macOS) or %APPDATA%\Claude\claude_desktop_config.json (Windows)

Capabilities & Tool Schemas (14)Self-reported

Inspect callable tools, capabilities, and parameters exposed to AI agents by Fda Risk Radar Mcp.

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

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 (legacy https://radar.healthai.com/api/mcp still serves)
Transport: Streamable HTTP (JSON-RPC 2.0)
Auth: none for anonymous access (30 requests/min per client); an optional X-API-Key header enables the separately assigned metered allowance.
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:

bash

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

jsonc

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

Terminal

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

Terminal

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.

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

View all alternatives

Frequently Asked Questions about Fda Risk Radar Mcp

How do I install the thehealthai/fda-risk-radar-mcp MCP server?

Add the following block to your claude_desktop_config.json under mcpServers: "mcpServers": { "fda-risk-radar-mcp": { "command": "npx", "args": ["-y", "thehealthai/fda-risk-radar-mcp"] } }

What does thehealthai/fda-risk-radar-mcp do?

Is the thehealthai/fda-risk-radar-mcp MCP server free to use?

Yes. thehealthai/fda-risk-radar-mcp is listed on AllMCPs as a free, open Model Context Protocol server you can install into Claude Desktop, Cursor, or any MCP-compatible client.

Technical Specs & Signals

TransportSTDIO

RuntimeNode.js

Health CheckActive

CategoryDeveloper Tools

Installs0

GitHub stars0

51Quality signal: Fair · 51/100How 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 ownership8/20

Documentation & tools30/30

Adoption0/15

Community engagement0/10

A guidance signal from public completeness & health data — not a user rating. New listings start lower and rise as they add docs, get verified, and grow adoption. Signals we can't observe for a listing are skipped, not counted against it.

★ Featured

AllMCPs Server

The official MCP server for AllMCPs.com - submit and manage tools directly from your AI.

Explore Server →

Own this project?

This directory is pre-filled from public sources. Claim via GitHub README, site badge, or DNS TXT to get the verified badge and attach your website.

Free dofollow backlink: after claiming, verify your product site and place a dofollow AllMCPs badge — we recheck it stays live.

Claim & get free dofollow

Promote this listing

Optional paid placement. Free listings stay free forever.

Featured boost7 days in the spotlight · from $12/wk

Weeks

→ Runs until Aug 15, 2026

Category sponsorTop-of-category sponsorship · from $18/wk

Weeks

→ Runs until Aug 15, 2026

Cancel anytime — no long-term lock-in.

Share & Embed

Add our SVG badge (dark/light directory styles) or embeddable widget to your site.

Explore more

More in 💻 Developer Tools →Best MCP servers for Developers →Alternatives to Fda Risk Radar Mcp →Install in Claude Desktop Install in Cursor Install in VS Code