A set of automatic rules that directs questions about FDA regulation of software and medical-device AI to specialised tools. FDA is the United States agency that regulates medicines and medical devices; SaMD means software as a medical device.

Use it when assessing an AI medical device, choosing an FDA pathway, classifying software, preparing a change-control plan, or reviewing machine-learning practices.

It helps prevent regulatory questions from being answered without the relevant classification and approval context. The rules identify topics such as 510(k), PMA, De Novo, PCCP, and good machine-learning practice.

How CSOAI-ORG/fda-samd-mcp configures Cursor

Reuse

Borrowing it

Nothing to install: this file belongs to CSOAI-ORG/fda-samd-mcp. Take a copy, put it at the same path in your own repository, and replace the rules that are about this project with yours.

Copy the file

curl -O https://raw.githubusercontent.com/CSOAI-ORG/fda-samd-mcp/main/.cursorrules

Clone the repo

git clone --depth 1 https://github.com/CSOAI-ORG/fda-samd-mcp

Made for: Cursor.

Wrote this? Show the measurements

A badge with what this costs and how it scanned, read live from this page, so it follows the numbers instead of freezing them. Markdown for a README, HTML for a documentation site or a project page.

README.md

[![agentmods](https://agentmods.dev/badge/rules/csoai-org/fda-samd-mcp/cursorrules/github.svg)](https://agentmods.dev/rules/csoai-org/fda-samd-mcp/cursorrules)

Your own site

<a href="https://agentmods.dev/rules/csoai-org/fda-samd-mcp/cursorrules"><img src="https://agentmods.dev/badge/rules/csoai-org/fda-samd-mcp/cursorrules/github.svg" alt="Measured on agentmods" height="20"></a>

Or the 80×15 button, for a site that already has a row of RSS and ATOM ones. Only the verdict fits; the numbers stay here.

Your own site · 80×15

<a href="https://agentmods.dev/rules/csoai-org/fda-samd-mcp/cursorrules"><img src="https://agentmods.dev/badge/rules/csoai-org/fda-samd-mcp/cursorrules.svg" alt="Reviewed on agentmods" width="80" height="20"></a>

Per session 195 This file is loaded in full into every session.

When invoked 195 The same file — it is already loaded in full.

Security scan A 0 findings. A grade says what 26 rules found in the file — not that it is safe.

Origin original No closer match found in the catalogue.

Token cost

What it costs to keep this loaded

Counted locally with the o200k_base tokenizer, which is exact for GPT models; Claude uses its own tokenizer and its counts differ. Treat this as one consistent yardstick across the catalogue rather than a bill. Prices are per million input tokens.

Model	Per session	Once invoked
Fable 5.1	$0.00195	$0.00195
Opus 5.5	$0.00078	$0.00078
Sonnet 5.5	$0.00039	$0.00039
Haiku 4.5	$0.00019	$0.00019

Measured 1mo ago against content hash 405d8cc3c0ee, method: parsed. Prices are Anthropic first-party input rates as of 2026-10-07, from the pricing page.

Security

Grade A, and why

cursorrules scanned grade A with 0 findings against 26 rules in 11 categories — prompt injection, anti-refusal, data exfiltration, privilege escalation, supply chain, agent snooping, system-prompt leakage, SSRF and excessive agency — measured 1mo ago.

A static scan of the body, not an audit. Every finding is printed with the line that produced it so you can judge whether it matters here. A mod is markdown that instructs an agent; that is exactly why what it instructs is worth reading.

Nothing flagged

None of the 26 patterns this scan looks for appear in this file: no shell pipes, no recursive deletes, no credential paths, no hidden text, no instruction-override or anti-refusal phrasing, no agent-config snooping. That is not a guarantee, it is the absence of the things that are checkable.

.cursorrules · 14 lines

What it actually says

FDA AI/ML SaMD Compliance MCP - Auto-trigger Rules

When the user asks about FDA, SaMD, 510(k), PMA, De Novo, PCCP, GMLP, AI/ML medical device, use fda-samd-mcp tools:

classify_sw_device: FDA SaMD vs SiMD classification + IMDRF risk framework
regulatory_pathway: 510(k) / De Novo / PMA pathway selection
pccp_template: Predetermined Change Control Plan generator (locked vs adaptive AI)
good_ml_practice: FDA Good Machine Learning Practice (GMLP) 10 principles
ai_ml_action_plan: FDA AI/ML Action Plan focus area assessment

Install: pip install fda-samd-mcp

By MEOK AI Labs — industry governance MCP. Pairs with meok-attestation-api for signed compliance certs.

Changes

What this file has done since we first saw it

Hashed on every crawl. A supply-chain change to an agent config is a question of when, not whether, so the history is kept rather than the latest state alone.

1mo ago First seen · 14 lines · 195 tokens per session scan A 405d8cc3c0ee

Subscribe to this mod's changes

cursorrules is a cursor rule published in the GitHub repository CSOAI-ORG/fda-samd-mcp (1 stars, last pushed 19d ago), licensed MIT. It adds 195 tokens to every session, about $0.0008 per session on Opus 5.5. A static security scan graded it A with 0 findings. No closer match exists in the catalogue, so it is treated as the original; first seen 2026-08-31.

AI/ML Legal and compliance Security fda mcp medical-device meok samd

fda-samd-mcp: Cursor rule for Cursor

Borrowing it

Wrote this? Show the measurements

What it costs to keep this loaded

Grade A, and why

Nothing flagged

What it actually says

FDA AI/ML SaMD Compliance MCP - Auto-trigger Rules

What this file has done since we first saw it

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