# openFDA Regulatory Metadata

Resolve drug names and application numbers to FDA records, or look up device submissions and classifications. Useful when an agent needs regulatory metadata by identifier.

- MCP server · `type=mcp` · Claude Code, Codex, Cursor, GitHub Copilot, Windsurf (Devin Desktop), Cline, Zed, Gemini CLI
- Author: Black-Swan-Causal-Labs
- License: MIT · policy=link-only · description only; the file stays with the author
- Source: https://github.com/Black-Swan-Causal-Labs/openfda-mcp
- Updated: 2026-08-07
- HTML: https://affpapa.org/en/nevibecode/mcp/openfda-regulatory-metadata

## What it does

The server queries openFDA to connect a drug’s brand or generic name with application numbers, then retrieve Drugs@FDA records for NDA, BLA, or ANDA identifiers. For devices, it can look up K, DEN, P, or H submissions and map product codes to a class and medical specialty. One tool runs the full lookup from submission number to device category.

To add it to Codex, run `codex mcp add openfda-regulatory-metadata -- uvx openfda-mcp`. An API key is optional. Without one, openFDA permits 40 requests per minute and 1,000 per day; a free key raises those limits for larger sweeps. Temporary request failures are retried and then surfaced as errors, rather than returned as a genuine missing record.

Treat `screen_for_rwe_signals` as an experimental candidate finder: its output needs human review and should not be reported as confirmed findings. For HDE submissions, the server infers device class III from the regulatory pathway, while medical specialty remains unavailable.

## Requirements
- Needs: Python and uv (commands run via uvx)

## Install

### Claude Code (native platform)

**Platform CLI**
```bash
claude mcp add openfda-mcp -- uvx openfda-mcp
```
uvx runs the command named after the package; if the README names another one, use uvx --from openfda-mcp <command>

### Codex

**Platform CLI**
```bash
codex mcp add openfda-regulatory-metadata -- uvx openfda-mcp
```
uvx runs the command named after the package; if the README names another one, use uvx --from openfda-mcp <command>

### Cursor

**Config file**
File `.cursor/mcp.json`:
```json
{
    "mcpServers": {
        "openfda-regulatory-metadata": {
            "command": "uvx",
            "args": [
                "openfda-mcp"
            ]
        }
    }
}
```
uvx runs the command named after the package; if the README names another one, use uvx --from openfda-mcp <command>

### GitHub Copilot

**Config file**
File `.vscode/mcp.json`:
```json
{
    "servers": {
        "openfda-regulatory-metadata": {
            "type": "stdio",
            "command": "uvx",
            "args": [
                "openfda-mcp"
            ]
        }
    }
}
```
uvx runs the command named after the package; if the README names another one, use uvx --from openfda-mcp <command>

### Gemini CLI

**Platform CLI**
```bash
gemini mcp add openfda-regulatory-metadata uvx openfda-mcp
```
uvx runs the command named after the package; if the README names another one, use uvx --from openfda-mcp <command>

## When to use it
- resolve drug names to FDA application numbers
- retrieve Drugs@FDA records by NDA, BLA, or ANDA
- map device submissions to a class and specialty
- screen drug labels for possible RWE signals

## Example prompts
- Find FDA application numbers for the drug named `drug name`.
- Look up application `BLA 125123/2058` and return its regulatory metadata.
- Determine the device class for submission `DEN160026`.

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