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fda-med-device

fda-med-device is a skill for Claude Code from jgsystemsconsulting/jgs-se-knowledge-packs. It costs 279 tokens per session (3,567 once invoked), scanned A, original, no licence file.

Reference notes on US Food and Drug Administration rules for software used in medical devices. The FDA is the US regulator for medical products; the notes cover quality rules, device-software guidance, and premarket routes such as 510(k), De Novo, and PMA.

In plain words
What is it for?
Use it to research medical-device software regulation, quality-system obligations, and preparation for FDA premarket submissions.
Why use it?
It gathers public FDA sources in one place to help teams understand possible regulatory routes and submission requirements.

Skill for Claude Code

Written for Claude Code: shipped in a Claude Code plugin.

Part of the jgs-se-knowledge-packs plugin — 83 skills shipped together

not rated 54repo +62 3d ago A scan 279 tokens custom licence

Good fit Use it to research medical-device software regulation, quality-system obligations, and preparation for FDA premarket submissions.

Compare 6 skills from other repositories ↓
Install with agentmods
npx agentmods add skills/jgsystemsconsulting/jgs-se-knowledge-packs/fda-med-device
View source ↗ jgsystemsconsulting/jgs-se-knowledge-packs jgsystemsconsulting.github.io
Install

Getting it into your agent

One page per mod, every tool's command on it. A separate URL per tool would split the same page into five that compete with each other.

Any agent
npx skills add jgsystemsconsulting/jgs-se-knowledge-packs --skill fda-med-device
Clone the repo
git clone --depth 1 https://github.com/jgsystemsconsulting/jgs-se-knowledge-packs

Made for: Claude Code.

Or install jgs-se-knowledge-packs, the plugin that ships this one along with the rest of its 83 skills.

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.

agentmods badge for fda-med-device

README.md
[![agentmods](https://agentmods.dev/badge/skills/jgsystemsconsulting/jgs-se-knowledge-packs/fda-med-device/github.svg)](https://agentmods.dev/skills/jgsystemsconsulting/jgs-se-knowledge-packs/fda-med-device)
Your own site
<a href="https://agentmods.dev/skills/jgsystemsconsulting/jgs-se-knowledge-packs/fda-med-device"><img src="https://agentmods.dev/badge/skills/jgsystemsconsulting/jgs-se-knowledge-packs/fda-med-device/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.

agentmods 80×15 button for fda-med-device

Your own site · 80×15
<a href="https://agentmods.dev/skills/jgsystemsconsulting/jgs-se-knowledge-packs/fda-med-device"><img src="https://agentmods.dev/badge/skills/jgsystemsconsulting/jgs-se-knowledge-packs/fda-med-device.svg" alt="Reviewed on agentmods" width="80" height="20"></a>
Per session 279 Skills are progressive disclosure: only the name and description are preloaded; the body loads when the skill is used.
When invoked 3,567 The whole file, excluding the scripts and references it only reads on demand.
Security scan A 0 findings. A grade says what 26 rules found in the file — not that it is safe.
Origin unknown 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.

ModelPer sessionOnce invoked
Fable 5.1 $0.00279 $0.03567
Opus 5.5 $0.00112 $0.01427
Sonnet 5.5 $0.00056 $0.00713
Haiku 4.5 $0.00028 $0.00357

Measured 22d ago against content hash 8d7ba143bd30, method: parsed. Prices are Anthropic first-party input rates as of 2026-10-07, from the pricing page.

Security

Grade A, and why

fda-med-device 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 22d 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.

packs/fda-med-device/SKILL.md · 123 lines

The source is not reproduced here

A licence we could not identify

The repository carries a LICENSE file, but it is custom or dual enough that GitHub cannot name it and neither can this catalogue. Unknown terms are not permission, so the body is not copied here. Read the licence at the source and decide for yourself.

Read it on GitHub

Files

What ships with it

16 files beside SKILL.md in the same directory: the scripts, references and assets a skill reads on demand. Not counted in the per-session cost; read them before you install if any of them is executable.

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.

  1. 22d ago First seen · 123 lines · 279 tokens per session scan A 8d7ba143bd30

Subscribe to this mod's changes

fda-med-device is a skill published in the GitHub repository jgsystemsconsulting/jgs-se-knowledge-packs (54 stars, last pushed 3d ago), with no licence file. It adds 279 tokens to every session and 3,567 once invoked, about $0.0011 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 2026-10-15.

Claude CodeLegal and complianceagent-skillsdodfaagaoknowledge-packs
Related

fda-med-device compared with skills from other repositories

fda-med-device next to 6 skills from other repositories
ModTypeStarsLast pushLicenceScanTokensWorks with
fda-med-devicejgsystemsconsulting/jgs-se-knowledge-packsSkill543d agononeA279Claude Code
legal-holdanthropics/claude-for-legalSkill9.9ktodayApache-2.0A68Claude Code
specification-writingwanshuiyin/Auto-claude-code-research-in-sleepSkill19kyesterdayMITA49Claude Code
terms-of-servicegenspark-ai/genofficeSkill12kyesterdayApache-2.0A32Claude Code, Codex
gesellschaftsrechtliche-satzungen-agbKlotzkette/claude-fuer-deutsches-rechtSkill1.8kyesterdayApache-2.0A69Claude Code
ai-risk-managementbriiirussell/cybersecurity-skillsSkill5075d agoMITA180Claude Code
ad-policy-checkgooseworks-ai/goose-skillsSkill1.3ktodayMITA128Claude Code, Codex