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fda-consultant-specialist

95 / 100 · Low risk

Fine to try. Some of what it can do is expected: a coding skill usually runs build and test commands.

By LeoYeAI/agent-master-skills (GitHub) · coding · 2,186 stars · scanned at commit 8f88f9a

FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QSR (21 CFR 820) compliance, HIPAA assessments, and device cybersecurity. Use when user mentions FDA submission, 510(k), PMA, De Novo, QSR, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity.

Works with any agent that supports SKILL.md skills.

What this skill can do

Install

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

if [ -e ~/.agents/skills/'fda-consultant-specialist' ] || [ -L ~/.agents/skills/'fda-consultant-specialist' ]; then echo 'A skill folder named fda-consultant-specialist already exists — not replacing it' >&2; false; else d=$(mktemp -d) && git clone --quiet --filter=blob:none --no-checkout 'https://github.com/LeoYeAI/agent-master-skills' "$d" && git -C "$d" checkout --quiet '8f88f9a0dd5a1075d4f0c7626f9d960844d57575' -- 'skills/fda-consultant-specialist' && mkdir -p ~/.agents/skills && cp -R "$d"/'skills/fda-consultant-specialist' ~/.agents/skills/'fda-consultant-specialist' && 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-consultant-specialist' ~/.claude/skills/'fda-consultant-specialist' (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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