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fda-med-device

100 / 100 · Low risk

Fine to try.

By jgsystemsconsulting/jgs-se-knowledge-packs (GitHub) · coding · 70 stars · scanned at commit 3bf1e13

Reconstructed reference notes on US FDA medical-device software regulation, built from seven public-domain FDA sources (the QMSR final rule 89 FR 7496, FDA device software guidance documents, and the eSTAR program page; pinned 2026-10-12). Use for regulatory pathways and premarket submissions (510(k), De Novo, PMA, eSTAR), premarket software documentation levels (Basic or Enhanced), software validation and Computer Software Assurance, the Quality Management System Regulation (QMSR, 21 CFR 820),…

Works with any agent that supports SKILL.md skills.

What this skill can do

We found nothing in the files we read that matches our rules. That does not prove the skill is safe: see the limits of static scanning.

Install

Paste this into your terminal. It downloads exactly the version we scanned, not whatever is newest.

if [ -e ~/.agents/skills/'fda-med-device' ] || [ -L ~/.agents/skills/'fda-med-device' ]; then echo 'A skill folder named fda-med-device already exists — not replacing it' >&2; false; else d=$(mktemp -d) && git clone --quiet --filter=blob:none --no-checkout 'https://github.com/jgsystemsconsulting/jgs-se-knowledge-packs' "$d" && git -C "$d" checkout --quiet '3bf1e1338acf4cb83e9339ce535228635165f288' -- 'packs/fda-med-device' && mkdir -p ~/.agents/skills && cp -R "$d"/'packs/fda-med-device' ~/.agents/skills/'fda-med-device' && rm -rf "$d"; fi

Codex reads ~/.agents/skills directly. For Claude Code, Cursor, Copilot, Gemini CLI, Antigravity or OpenCode, also link it. For Claude Code: ln -s ~/.agents/skills/'fda-med-device' ~/.claude/skills/'fda-med-device' (other agents: ~/.cursor/skills, ~/.copilot/skills, ~/.gemini/skills, ~/.gemini/config/skills, ~/.config/opencode/skills). Or install through the finder skill, which does both.

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