Is Fda Regulations free?

Yes, Fda Regulations is free to use.

How do I install Fda Regulations?

Fda Regulations is a remote plugin. You do not need to install anything locally. Add the server URL to your AI app's MCP configuration and you are ready to go.

Is Fda Regulations safe to use?

Yes. Fda Regulations passed MCP Marketplace's automated security scan with a score of 10/10 (low risk). Every server on MCP Marketplace is security-scanned before it's listed; see the full security report on this page for the findings and permissions.

What AI apps work with Fda Regulations?

Fda Regulations uses the Model Context Protocol (MCP) and works with any MCP-compatible AI app, including Claude, ChatGPT / Codex, Gemini, Copilot, Cursor, and more.

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Fda Regulations MCP Server

by Pipeworx Io

Developer ToolsLow Risk10.0MCP RegistryRemote

Free

Server data from the Official MCP Registry

FDA Regulations MCP — US Food & Drug Administration regulations (21 CFR).

About

FDA Regulations MCP — US Food & Drug Administration regulations (21 CFR).

Remote endpoints: streamable-http: https://gateway.pipeworx.io/fda-regulations/mcp

Security Report

10.0

Low Risk10.0Low Risk

Valid MCP server (1 strong, 0 medium validity signals). No known CVEs in dependencies. Imported from the Official MCP Registry. Trust signals: trusted author (1257/1270 approved). 1 finding(s) downgraded by scanner intelligence.

33 tools verified · Open access · 1 issue found

Security scores are indicators to help you make informed decisions, not guarantees. Always review permissions before connecting any MCP server.

Permissions Required

This plugin requests these system permissions. Most are normal for its category.

HTTP Network Access

Connects to external APIs or services over the internet.

How to Connect

Remote Plugin

No local installation needed. Your AI client connects to the remote endpoint directly.

Add this to your MCP configuration to connect:

{
  "mcpServers": {
    "io-github-pipeworx-io-fda-regulations": {
      "url": "https://gateway.pipeworx.io/fda-regulations/mcp"
    }
  }
}

Documentation

View on GitHub

From the project's GitHub README.

mcp-fda-regulations

FDA Regulations MCP — US Food & Drug Administration regulations (21 CFR).

Part of Pipeworx — an MCP gateway connecting AI agents to 1476+ live data sources.

Tools

Tool Description

fda_regulation Get the full text of one FDA regulation — a US Food & Drug Administration rule codified in 21 CFR — by its citation. Returns the exact regulatory wording currently in force. Answers "what does 21 CFR 211 require", "what is the FDA regulation for X", "does the FDA require X", "read 21 CFR 211.100", "the FDA good manufacturing practice rule". Forgiving citation input: "211.100", "21 CFR 211.100", "§211.100", even "211.100(a)" (paragraph stripped to the section). Covers 21 CFR part 211 current good manufacturing practice (cGMP / GMP) for finished drugs, part 210 cGMP general, part 820 quality system regulation / QMSR for medical devices, part 801 medical device labeling, part 101 food labeling / nutrition facts, part 314 new drug applications (NDA/ANDA), part 807 device establishment registration, part 111 dietary supplement cGMP, part 1308 controlled substance schedules — the whole of Title 21 (food, drugs, devices, cosmetics, biologics). This is FDA REGULATIONS (the rules/regulatory text); for FDA DATA (drug labels, adverse events, recalls) use the openfda tools. Pass a whole part (e.g. "211" or "820") to get that part's section list. Example: fda_regulation({ citation: "211.100" }) -> written procedures / process control; fda_regulation({ citation: "21 CFR 101.9" }) -> nutrition labeling. Keyless.

fda_search Keyword search across FDA regulations — US Food & Drug Administration rules in 21 CFR. Answers "what FDA regulations cover X", "the FDA regulation / rule about X", "find the FDA requirement for X". Great for topics: good manufacturing practice (GMP / cGMP), quality system regulation, medical device labeling, drug labeling, nutrition facts / food labeling, new drug applications, dietary supplements, cosmetics, biologics, controlled substances, current good manufacturing practice for drugs and devices. Returns matching FDA regulations with citation (21 CFR), heading, excerpt, and source URL. This searches FDA REGULATIONS (regulatory text); for FDA DATA (drug labels, adverse events, recalls) use the openfda tools. Example: fda_search({ query: "medical device labeling" }); fda_search({ query: "good manufacturing practice", limit: 15 }). Keyless.

Tool	Description
`fda_regulation`	Get the full text of one FDA regulation — a US Food & Drug Administration rule codified in 21 CFR — by its citation. Returns the exact regulatory wording currently in force. Answers "what does 21 CFR 211 require", "what is the FDA regulation for X", "does the FDA require X", "read 21 CFR 211.100", "the FDA good manufacturing practice rule". Forgiving citation input: "211.100", "21 CFR 211.100", "§211.100", even "211.100(a)" (paragraph stripped to the section). Covers 21 CFR part 211 current good manufacturing practice (cGMP / GMP) for finished drugs, part 210 cGMP general, part 820 quality system regulation / QMSR for medical devices, part 801 medical device labeling, part 101 food labeling / nutrition facts, part 314 new drug applications (NDA/ANDA), part 807 device establishment registration, part 111 dietary supplement cGMP, part 1308 controlled substance schedules — the whole of Title 21 (food, drugs, devices, cosmetics, biologics). This is FDA REGULATIONS (the rules/regulatory text); for FDA DATA (drug labels, adverse events, recalls) use the openfda tools. Pass a whole part (e.g. "211" or "820") to get that part's section list. Example: fda_regulation({ citation: "211.100" }) -> written procedures / process control; fda_regulation({ citation: "21 CFR 101.9" }) -> nutrition labeling. Keyless.
`fda_search`	Keyword search across FDA regulations — US Food & Drug Administration rules in 21 CFR. Answers "what FDA regulations cover X", "the FDA regulation / rule about X", "find the FDA requirement for X". Great for topics: good manufacturing practice (GMP / cGMP), quality system regulation, medical device labeling, drug labeling, nutrition facts / food labeling, new drug applications, dietary supplements, cosmetics, biologics, controlled substances, current good manufacturing practice for drugs and devices. Returns matching FDA regulations with citation (21 CFR), heading, excerpt, and source URL. This searches FDA REGULATIONS (regulatory text); for FDA DATA (drug labels, adverse events, recalls) use the openfda tools. Example: fda_search({ query: "medical device labeling" }); fda_search({ query: "good manufacturing practice", limit: 15 }). Keyless.

Quick Start

Add to your MCP client (Claude Desktop, Cursor, Windsurf, etc.):

{
  "mcpServers": {
    "fda-regulations": {
      "url": "https://gateway.pipeworx.io/fda-regulations/mcp"
    }
  }
}

What this endpoint actually serves

tools/list at https://gateway.pipeworx.io/fda-regulations/mcp returns the tools in the table above plus the shared Pipeworx meta-tools — ask_pipeworx, discover_tools, search_within, remember/recall and the rest of the gateway-wide set. So the tool count you see is larger than this table: a single-pack endpoint currently lists roughly 30 shared tools alongside the pack's own. The connection's initialize response states its exact scope, and is the authoritative answer for a given day.

This is deliberate, not multiplexing by accident. The meta-tools are what let a scoped connection answer a question this pack does not cover — via ask_pipeworx, which routes across the whole catalog — without you adding a second MCP server. There is currently no way to mount a pack endpoint without them; if the extra schemas cost you more context than the routing is worth, connect to the full gateway once rather than to several pack endpoints.

Or connect to the full Pipeworx gateway to get every pack's tools listed directly, instead of just this one's:

{
  "mcpServers": {
    "pipeworx": {
      "url": "https://gateway.pipeworx.io/mcp"
    }
  }
}

Both URLs reach the same gateway and the same 1476+ data sources. The only difference is which pack's tools are listed directly; ask_pipeworx reaches all of them from either one.

Using with ask_pipeworx

Instead of calling tools directly, you can ask questions in plain English — this works on the pack endpoint above as well as on the full gateway:

ask_pipeworx({ question: "your question about Fda Regulations data" })

The gateway picks the right tool and fills the arguments automatically.

License

MIT

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Fda Regulations MCP Server

About

Security Report

Findings (1)

Permissions Required

How to Connect

Documentation

mcp-fda-regulations

Tools

Quick Start

What this endpoint actually serves

Using with ask_pipeworx

More

License

Reviews

No reviews yet

More Developer Tools MCP Servers

Git

Fetch

Toleno

mcp-creator-python

MCP Marketplace

MarkItDown