Fda Consultant Specialist

If you're navigating FDA submissions for medical devices, this gives you a structured consultant's playbook covering 510(k) and PMA pathways, QSR compliance frameworks, and HIPAA requirements. It walks through predicate device analysis, design controls under 21 CFR 820.30, and cybersecurity documentation including SBOM requirements. The decision trees for pathway selection are solid, and it references inspection readiness checklists. Most useful when you're planning a regulatory strategy or preparing submission documentation and need the CFR citations and process steps laid out systematically. It won't replace actual regulatory counsel, but it organizes the framework well enough to structure your compliance work and identify gaps before you involve lawyers.

skills.sh installs: 352
GitHub stars: 33.2K
last updated: Aug 21, 2026

View on GitHub

Install

$ npx -y skills add davila7/claude-code-templates --skill fda-consultant-specialist --agent claude-code

Installs into .claude/skills of the current project.

Files

Senior FDA Consultant and Specialist

Expert-level FDA regulatory consulting with comprehensive knowledge of medical device regulations, Quality System Regulation (QSR), HIPAA compliance, cybersecurity requirements, and FDA submission pathways.