FDA Approvals MCP Server

FDA drug approvals, 510(k) device clearances, recalls and adverse-event reports.

Remote serverstreamable-httpTypeScript

What is the FDA Approvals MCP Server?

FDA drug approvals, 510(k) device clearances, recalls and adverse-event reports.

What the server does

Hosted MCP server over openFDA. Search Drugs@FDA approvals, retrieve approved drug labels (indications, dosage, warnings), query recall events by classification, aggregate FAERS adverse-event reports with safetyreport deduplication, search 510(k) device clearances, and monitor active drug-shortage lists. For pharma research, clinical decision support, and regulatory LLMs.

More MCP options

Compare MCP servers by category, or browse hosted MCP servers if you prefer an endpoint over a local process.

Maintainer setup documentation.

Recorded tools

Check the linked publisher documentation and your connected client's tool list. Names and availability can vary with the server version and account permissions.

ToolWhat it does
fda_drug_approval_searchsponsor?, brand?, generic?, date_from?, date_to?, limit?
fda_drug_labelname
fda_recall_searchclassification?, date_from?, date_to?, limit?
fda_adverse_eventsdrug, limit?
fda_510k_searchquery?, applicant?, limit? — Team+
fda_drug_shortageslimit? — Team+

Example prompts to try

  • “Use FDA Approvals to fda drug approval search.”
  • “Use FDA Approvals to fda drug label.”
  • “Use FDA Approvals to fda recall search.”

Frequently asked questions

FDA drug approvals, 510(k) device clearances, recalls and adverse-event reports. Confirm the tools offered by your installed version in the connected client. Tool availability and permissions depend on the server and account configuration.