Fda Consultant Specialist

You know how navigating FDA regulations can turn into a research project every time you need to verify a requirement or understand a compliance pathway? This puts an FDA consultant in your terminal who can answer questions about regulatory requirements, device classifications, clinical trial rules, and submission processes. Use it when you're scoping a medical device project, prepping documentation, or trying to figure out if your software qualifies as a medical device in the first place. It won't replace your actual regulatory team for submissions, but it's solid for initial research and sanity checking your assumptions before you loop in the expensive consultants.

skills.sh installs: 782
GitHub stars: 29.5K
last updated: Aug 21, 2026

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Install

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

Installs into .claude/skills of the current project.

Files

FDA Consultant Specialist

FDA regulatory consulting for medical device manufacturers covering submission pathways, the Quality Management System Regulation (QMSR, 21 CFR Part 820 — formerly the QSR), HIPAA compliance, and device cybersecurity requirements.

FDA Pathway Selection
510(k) Submission Process
QMSR Compliance (formerly QSR)
HIPAA for Medical Devices
Device Cybersecurity
Resources

FDA Pathway Selection

Determine the appropriate FDA regulatory pathway based on device classification and predicate availability.

Decision Framework

Predicate device exists?
├── YES → Substantially equivalent?
│   ├── YES → 510(k) Pathway
│   │   ├── No design changes → Abbreviated 510(k)
│   │   ├── Manufacturing only → Special 510(k)
│   │   └── Design/performance → Traditional 510(k)
│   └── NO → PMA or De Novo
└── NO → Novel device?
    ├── Low-to-moderate risk → De Novo
    └── High risk (Class III) → PMA