Skill · em Documentar e entregar

fda-consultant-specialist

Senior FDA consultant and specialist for medical device companies including HIPAA compliance and requirement management. Provides FDA pathway expertise, QSR compliance, cybersecurity guidance, and regulatory submission support. Use for FDA submission planning, QSR compliance assessments, HIPAA…

Procedência

Origem: davila7/claude-code-templates
Caminho: cli-tool/components/skills/enterprise-communication/fda-consultant-specialist
Versão fixada: 57f899e5394bb8ca166f38eacae8f0853cbfe033
Licença: MIT
Espelhado em 25/09/2026
nenhum download no Claude Code Templates (lido em 25/09/2026)

Antes de instalar

4 arquivos · 13,3 KB · inclui 1 script que executa: scripts/example.py

Instalar na sua CLI

O comando baixa a versão fixada (commit 57f899e) direto da origem, para a pasta que a CLI lê. Precisa de curl (macOS e Linux); no Windows não há comando, porque o Rook Labs é para macOS.

Claude Code

Neste projeto: instala em .claude/skills/fda-consultant-specialist/.

d=".claude/skills/fda-consultant-specialist"
u="https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/cli-tool/components/skills/enterprise-communication/fda-consultant-specialist"
curl -fsSL --create-dirs \
  -o "$d/SKILL.md" "$u/SKILL.md" \
  -o "$d/assets/example_asset.txt" "$u/assets/example_asset.txt" \
  -o "$d/references/api_reference.md" "$u/references/api_reference.md" \
  -o "$d/scripts/example.py" "$u/scripts/example.py" \
  -o "$d/LICENSE" "https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/LICENSE"

Global: instala em ~/.claude/skills/fda-consultant-specialist/.

d="$HOME/.claude/skills/fda-consultant-specialist"
u="https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/cli-tool/components/skills/enterprise-communication/fda-consultant-specialist"
curl -fsSL --create-dirs \
  -o "$d/SKILL.md" "$u/SKILL.md" \
  -o "$d/assets/example_asset.txt" "$u/assets/example_asset.txt" \
  -o "$d/references/api_reference.md" "$u/references/api_reference.md" \
  -o "$d/scripts/example.py" "$u/scripts/example.py" \
  -o "$d/LICENSE" "https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/LICENSE"

Codex

Neste projeto: instala em .agents/skills/fda-consultant-specialist/.

d=".agents/skills/fda-consultant-specialist"
u="https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/cli-tool/components/skills/enterprise-communication/fda-consultant-specialist"
curl -fsSL --create-dirs \
  -o "$d/SKILL.md" "$u/SKILL.md" \
  -o "$d/assets/example_asset.txt" "$u/assets/example_asset.txt" \
  -o "$d/references/api_reference.md" "$u/references/api_reference.md" \
  -o "$d/scripts/example.py" "$u/scripts/example.py" \
  -o "$d/LICENSE" "https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/LICENSE"

Global: instala em ~/.agents/skills/fda-consultant-specialist/.

d="$HOME/.agents/skills/fda-consultant-specialist"
u="https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/cli-tool/components/skills/enterprise-communication/fda-consultant-specialist"
curl -fsSL --create-dirs \
  -o "$d/SKILL.md" "$u/SKILL.md" \
  -o "$d/assets/example_asset.txt" "$u/assets/example_asset.txt" \
  -o "$d/references/api_reference.md" "$u/references/api_reference.md" \
  -o "$d/scripts/example.py" "$u/scripts/example.py" \
  -o "$d/LICENSE" "https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/LICENSE"

Antigravity

Neste projeto: instala em .agents/skills/fda-consultant-specialist/.

d=".agents/skills/fda-consultant-specialist"
u="https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/cli-tool/components/skills/enterprise-communication/fda-consultant-specialist"
curl -fsSL --create-dirs \
  -o "$d/SKILL.md" "$u/SKILL.md" \
  -o "$d/assets/example_asset.txt" "$u/assets/example_asset.txt" \
  -o "$d/references/api_reference.md" "$u/references/api_reference.md" \
  -o "$d/scripts/example.py" "$u/scripts/example.py" \
  -o "$d/LICENSE" "https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/LICENSE"

Global: instala em ~/.gemini/antigravity-cli/skills/fda-consultant-specialist/.

d="$HOME/.gemini/antigravity-cli/skills/fda-consultant-specialist"
u="https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/cli-tool/components/skills/enterprise-communication/fda-consultant-specialist"
curl -fsSL --create-dirs \
  -o "$d/SKILL.md" "$u/SKILL.md" \
  -o "$d/assets/example_asset.txt" "$u/assets/example_asset.txt" \
  -o "$d/references/api_reference.md" "$u/references/api_reference.md" \
  -o "$d/scripts/example.py" "$u/scripts/example.py" \
  -o "$d/LICENSE" "https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/LICENSE"

Peça ao Rook

Já usa o Rook Labs? Cole no chat do Rook: instale a skill https://rooklabs.sh/marketplace/cct.fda-consultant-specialist

Prévia do SKILL.md

---
name: fda-consultant-specialist
description: Senior FDA consultant and specialist for medical device companies including HIPAA compliance and requirement management. Provides FDA pathway expertise, QSR compliance, cybersecurity guidance, and regulatory submission support. Use for FDA submission planning, QSR compliance assessments, HIPAA evaluations,…
---

# 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.

## Core FDA Regulatory Competencies

### 1. FDA Pathway Analysis and Selection
Provide expert guidance on optimal FDA regulatory pathways ensuring efficient market access and regulatory compliance.

**FDA Pathway Decision Framework:**
```
FDA REGULATORY PATHWAY SELECTION
├── Device Classification Determination
│   ├── Predicate device identification
│   ├── Classification database research
│   ├── Classification panel consultation
│   └── De Novo pathway evaluation
├── Submission Pathway Selection
│   ├── 510(k) Clearance Assessment
│   │   ├── Traditional 510(k)
│   │   ├── Special 510(k)
│   │   └── Abbreviated 510(k)
│   ├── PMA (Premarket Approval) Evaluation
│   │   ├── Original PMA
│   │   ├── Panel-track supplement
│   │   └── Real-time supplement
│   └── De Novo Classification Request
│       ├── Novel device evaluation
│       ├── Risk classification
│       └── Special controls development
└── Pre-submission Strategy
    ├── Q-Sub meeting planning
    ├── FDA feedback integration
    ├── Submission timeline optimization
    └── Risk mitigation planning
…

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