fda-consultant-specialist
About
This skill provides FDA regulatory guidance for medical device developers, specializing in submission pathways (510(k)/PMA/De Novo), QSR compliance, and device cybersecurity. Use it when a query involves FDA submissions, predicate devices, 21 CFR 820, or related compliance topics. It helps navigate premarket requirements and regulatory assessments.
Quick Install
Claude Code
Recommendednpx skills add openclaw/skills -a claude-code/plugin add https://github.com/openclaw/skillsgit clone https://github.com/openclaw/skills.git ~/.claude/skills/fda-consultant-specialistCopy and paste this command in Claude Code to install this skill
GitHub Repository
Frequently asked questions
What is the fda-consultant-specialist skill?
fda-consultant-specialist is a Claude Skill by openclaw. Skills package instructions and resources that Claude loads on demand, so Claude can perform fda-consultant-specialist-related tasks without extra prompting.
How do I install fda-consultant-specialist?
Use the install commands on this page: add fda-consultant-specialist to Claude Code as a plugin, or clone its repository into your skills directory, then restart Claude so it picks up the skill.
What category does fda-consultant-specialist belong to?
fda-consultant-specialist is in the Design category, tagged design.
Is fda-consultant-specialist free to use?
Yes. fda-consultant-specialist is listed on AIMCP and free to install. It runs inside Claude, so no separate service account is required to use the skill itself.
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