openFDA Regulatory Metadata — Claude Code MCP server
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.
claude mcp add openfda-mcp -- uvx openfda-mcpWhat openFDA Regulatory Metadata 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.
What it helps with
- 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 for the agent
- Find FDA application numbers for the drug named
drug name. - Look up application
BLA 125123/2058and return its regulatory metadata. - Determine the device class for submission
DEN160026.
How to install openFDA Regulatory Metadata
Platform CLI
claude mcp add openfda-mcp -- uvx openfda-mcpuvx runs the command named after the package; if the README names another one, use uvx --from openfda-mcp <command>
Platform CLI
codex mcp add openfda-regulatory-metadata -- uvx openfda-mcpuvx runs the command named after the package; if the README names another one, use uvx --from openfda-mcp <command>
Config file
{
"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>
Config file
{
"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>
Platform CLI
gemini mcp add openfda-regulatory-metadata uvx openfda-mcpuvx runs the command named after the package; if the README names another one, use uvx --from openfda-mcp <command>
Step by step, with commands for each platform: How to add an MCP server to Claude Code, Codex, Cursor, VS Code, Gemini CLI and more
Questions about openFDA Regulatory Metadata
How do I install openFDA Regulatory Metadata in Codex?
Run codex mcp add openfda-regulatory-metadata -- uvx openfda-mcp. Codex will add the server as an MCP tool.
What does openFDA Regulatory Metadata do?
It resolves drug names and application identifiers to FDA records, and looks up device classes and medical specialties.
Do I need an API key?
No. Without a key, openFDA allows 40 requests per minute and 1,000 per day. A free key increases the request limits.
