Machine access · MCP

Connect AI agents to FDA medical-device evidence.

One public MCP endpoint exposes 13 FDA and CMS tools for 510(k) precedent research, postmarket surveillance, reimbursement evidence, and compliance monitoring. The machine interface uses the same source boundaries and honesty rules as the console.

Endpoint

https://constat.dev/api/mcp

Streamable HTTP transport · public name Constat MCP · registry ID com.healthai/radar v0.5.3 · no auth required for read tools. In Claude Code: claude mcp add --transport http constat https://constat.dev/api/mcp

Want platform-specific setup and workflow examples? See how to connect ChatGPT, Claude, Codex, Cursor, VS Code, and agent frameworks.

Inspect the implementation and manifests in the Health AI GitHub repository.

Common FDA MCP workflows

510(k) research

Find similar devices, inspect source-quoted validation evidence, and trace predicate chains.

Postmarket & compliance

Query MAUDE and recall context, firm FDA histories, and monitored public-record changes.

Payment evidence

Trace clearance numbers to documented reimbursement mechanisms, codes, rates, and policies.

The 13 FDA and CMS tools, by track

Premarket · Precedent

device_evidence_lookup
Parsed 510(k) evidence for one device — every field with a verbatim source quote.
evidence_search
“Devices like mine” by product code, panel, applicant, clinical data, PCCP…
predicate_chain
Trace a device's predicate ancestry.
evidence_cohort_stats
Presence rates across the audited corpus — denominators always inline.

Post-deployment · Postmarket

device_postmarket_lookup
Recalls, MAUDE trend, and drift signals for one cleared device.
postmarket_search
Find devices by postmarket criteria — drift signals, recalls, rising MAUDE.
cohort_postmarket_stats
Cohort-level presence rates, never pooled.

Payment · Reimbursement

reimbursement_lookup
Clearance-to-payment pathway by K/DEN number or bare CPT code.
reimbursement_search
Pathways by mechanism — NTAP, Category I/III, HCPCS, LCD.
reimbursement_stats
Mechanism distribution with per-mechanism dollar spreads.

Compliance · Radar

device_risk_lookup
Category-level public FDA signal for a product code, with drivers and limits itemized.
firm_compliance_history
Source-bounded firm timeline: recalls, warning letters, and FEI-attributed 483 citations.
watchlist_diff
Monitored public-record changes since a reusable polling cursor.

One legacy compatibility tool, vehicle_risk_lookup, remains available for NHTSA make/model/year history but is not part of the FDA-device lifecycle product.

Try it raw

curl -s https://constat.dev/api/mcp \
  -H 'content-type: application/json' \
  -d '{"jsonrpc":"2.0","id":1,"method":"tools/call",
       "params":{"name":"evidence_search",
                 "arguments":{"panel":"Radiology","reports_any_sensitivity_metric":true}}}'

The endpoint speaks JSON-RPC — opening it in a browser returns a bare “method not allowed,” which is the endpoint working as intended. This page is its human-readable face.

Need higher-volume access or an internal integration?

Scope data fields, usage, licensing, source boundaries, and review requirements before connecting Constat to a production workflow.

Discuss team access