# thehealthai/fda-risk-radar-mcp [Health: Active] **Category:** 💻 Developer Tools **Repository:** https://github.com/thehealthai/fda-risk-radar-mcp **GitHub Stars:** 0 **Views:** 0 **Installs:** 0 **Upvotes:** 0 **Directory Page:** https://allmcps.com/mcp/thehealthai-fda-risk-radar-mcp ## Description 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. ## Tools Capabilities this server exposes over 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 - **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 ## Claude Desktop Quick Installation Heuristic fallback — verify the package name and runner against the repository README before running it. Uses `npx` (confidence: low): ```json "mcpServers": { "fda-risk-radar-mcp": { "command": "npx", "args": ["-y","thehealthai-fda-risk-radar-mcp"] } } ``` ## Documentation & README # Constat — 483 Risk Radar (MCP server) Constat 483 Risk Radar MCP server [![MCP Queen grade](https://mcpqueen.com/badge/com.healthai/radar.svg)](https://mcpqueen.com/s/com.healthai/radar) The MCP server behind [**Constat**](https://constat.dev) — 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`](https://registry.modelcontextprotocol.io) (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"] } } } ``` ```bash 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 ```bash 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](https://constat.dev/integrations), [architecture and trust boundaries](https://constat.dev/architecture), [privacy notice](https://constat.dev/privacy), and [support page](https://constat.dev/support). ## Related servers - [Clarity MCP](https://github.com/thehealthai/clarity-mcp) — condition-aware ingredient, product & supplement safety (verdict + evidence tier + citation). - [MCP Queen](https://github.com/mcpqueen/mcpqueen) — the graded MCP registry that independently probes and grades this server. ## About Built by [Health AI](https://healthai.com), the team behind [Constat](https://constat.dev). Informational only; verify against primary FDA/NHTSA sources. ## License MIT — see [LICENSE](LICENSE).