fda-mcp

Local MCP server exposing FDA medical-device intelligence tools. All data sources are public and keyless: openFDA (api.fda.gov), the fda.gov warning-letter endpoint (not in openFDA), and 510(k) summary PDFs from accessdata.fda.gov (parsed via pdftotext).

The server has no LLM inside — it is the toolbox. Your AI client (opencode, Claude Code, Claude Desktop, Cursor, VS Code Copilot) supplies the model and decides when to call the tools.

Requirements

• Bun (tested with 1.4.x)

• pdftotext (poppler-utils) on PATH — only needed for get_510k_summary

Related MCP server: fda-approvals-mcp

Run

bun src/index.ts    # speaks MCP over stdio; clients spawn this themselves

Tools

Most search tools accept count_by for aggregations (e.g. search_510k with count_by: "applicant.exact" = who files most under a product code).

Skill (for shell-capable agents — no server needed)

skills/fda-device-intel/SKILL.md teaches an agent with shell access (Claude Code, opencode, Codex CLI, Copilot agent mode) to query the same endpoints directly with curl — no process, no install beyond the markdown file:

One-liner install (Claude Code / any agent reading ~/.claude/skills/):

mkdir -p ~/.claude/skills/fda-device-intel && curl -fsSL -o ~/.claude/skills/fda-device-intel/SKILL.md https://raw.githubusercontent.com/happylemonprogramming/fda-mcp/main/skills/fda-device-intel/SKILL.md

Or paste the skill straight into any agent that can fetch URLs:

Fetch https://raw.githubusercontent.com/happylemonprogramming/fda-mcp/main/skills/fda-device-intel/SKILL.md and follow it to answer FDA medical-device questions.

Skill and MCP server share one knowledge source: get_query_guide serves the skill's body to MCP clients, so remote no-shell clients (Claude Desktop, ChatGPT, Teams/Copilot Studio) get the same guidance driving fda_fetch.

Connect a client

opencode

Add to opencode.json (project) or ~/.config/opencode/opencode.json:

{
  "mcp": {
    "fda": {
      "type": "local",
      "command": ["bun", "/home/lemon/Projects/fda-mcp/src/index.ts"],
      "enabled": true
    }
  }
}

Claude Code

claude mcp add fda -- bun /home/lemon/Projects/fda-mcp/src/index.ts

or in .mcp.json:

{
  "mcpServers": {
    "fda": {
      "command": "bun",
      "args": ["/home/lemon/Projects/fda-mcp/src/index.ts"]
    }
  }
}

Claude Desktop

~/.config/Claude/claude_desktop_config.json → same mcpServers block as Claude Code above.

Example prompts to try

• "Look up the product code for a bipolar laparoscopic coagulation device, then show me the 5 newest clearances under it."

• "Run a postmarket health check on POWERSEAL by Olympus."

• "Get the indications statement from K213042's summary PDF."

• "Any CDRH warning letters mentioning Medtronic?"

Caveats

• MAUDE data lags months behind real time.

• The warning-letter endpoint is an undocumented fda.gov internal API; it can change without notice. Keep request volume low.

• Name matching is keyword-based; brand/company collisions happen (a "Voyant" query matches an unrelated contact lens). Every tool output says so.

• Informational only, not regulatory advice; see https://open.fda.gov/terms/.