fda-consultant-specialist
FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QMSR (21 CFR 820, which incorporates ISO 13485:2016 by reference since 2026-02-02; formerly QSR) compliance, HIPAA assessments, and device cybersecurity. Use when user mentions FDA submission, 510(k), PMA, De Novo, QMSR, QSR, ISO 13485 for FDA, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity.
Profile →npx skills add alirezarezvani/claude-skills --skill fda-consultant-specialist --agent claude-code
Same command for any agent — swap --agent for codex, cursor, copilot.
Weekly change comes from our own snapshots, not the repository page — it measures attention, not adoption.
# 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. ## Table of Contents - [FDA Pathway Selection](#fda-pathway-selection) - [510(k) Submission Process](#510k-submission-process) - [QMSR Compliance (formerly QSR)](#qmsr-compliance-formerly-qsr) - [HIPAA for Medical Devices](#hipaa-for-medical-devices) - [Device Cybersecurity](#device-cybersecurity) - [Resources](#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 ``` ### Pathway Comparison | Pathway | When to Use | Timeline | User Fee (FY2024) | |---------|-------------|
- Table of Contents
- FDA Pathway Selection
- Decision Framework
- Pathway Comparison
- Pre-Submission Strategy
- 510(k) Submission Process
- Workflow
- Required Sections (21 CFR 807.87)
- Common RTA Issues
- QMSR Compliance (formerly QSR)
- Key Quality Subsystems (legacy QSR index → current ISO 13485:2016 clause)
- Design Controls Workflow (ISO 13485 §7.3; legacy QSR 820.30)
- CAPA Process (ISO 13485 §8.5.2/8.5.3; legacy QSR 820.100)
- HIPAA for Medical Devices
Track FDA submission status python scripts/fda_submission_tracker.py /path/to/project --type 510k Assess QMS documentation (legacy QSR section keys, mapped to ISO 13485 under QMSR) python scripts/qsr_compliance_checker.py /path/to/project --section 820.30 # legacy checklist key = ISO 13485 §7.3 (design & development) Run HIPAA risk assessment python scripts/hipaa_risk_assessment.py /path/to/project --category technical
What does the fda-consultant-specialist skill do?
FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QMSR (21 CFR 820, which incorporates ISO 13485:2016 by reference since 2026-02-02; formerly QSR) compliance, HIPAA assessments, and device cybersecurity. Use when user mentions FDA submission, 510(k), PMA, De Novo, QMSR, QSR, ISO 13485 for FDA, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity.
How do I install it?
Run `npx skills add alirezarezvani/claude-skills --skill fda-consultant-specialist --agent claude-code` — it drops the skill into your project so the agent can pick it up. Swap the --agent value for codex, cursor or copilot if you use one of those.
Where does this skill come from?
From alirezarezvani/claude-skills, a repository with 23,791 stars. We read it straight from the repository tree rather than a submitted listing, so what you see here is what is actually published.
Is a popular skill a good skill?
Not necessarily. Stars measure attention, not adoption — a repository can trend for a week and be abandoned. That is why we show the weekly change from our own snapshots next to the total, instead of a single flattering number.