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Manage — FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QSR (21 CFR 820) compliance, HIPAA assessments, and device cybersecurity. Use
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| name | fda-consultant-specialist |
| description | Manage — FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QSR (21 CFR 820) compliance, HIPAA assessments, and device cybersecurity. Use |
| executor | HYBRID |
| skill_id | business.ra-qm-team.fda-consultant-specialist |
| status | ADOPTED |
| security | {"level":"high","pii":false,"approval_required":true} |
| anchors | ["business","compliance","security","design"] |
| tier | 2 |
| input_schema | [{"name":"code_or_task","type":"string","description":"Code snippet, script, or task description to process","required":true}] |
| output_schema | [{"name":"plan","type":"string","description":"Strategic plan or design document"},{"name":"next_steps","type":"array","description":"List of recommended next steps"}] |
FDA regulatory consulting for medical device manufacturers covering submission pathways, Quality System Regulation (QSR), HIPAA compliance, and device cybersecurity requirements.
Determine the appropriate FDA regulatory pathway based on device classification and predicate availability.
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 | When to Use | Timeline | Cost |
|---|---|---|---|
| 510(k) Traditional | Predicate exists, design changes | 90 days | $21,760 |
| 510(k) Special | Manufacturing changes only | 30 days | $21,760 |
| 510(k) Abbreviated | Guidance/standard conformance | 30 days | $21,760 |
| De Novo | Novel, low-moderate risk | 150 days | $134,676 |
| PMA | Class III, no predicate | 180+ days | $425,000+ |
Reference: See fda_submission_guide.md for pathway decision matrices and submission requirements.
Phase 1: Planning
├── Step 1: Identify predicate device(s)
├── Step 2: Compare intended use and technology
├── Step 3: Determine testing requirements
└── Checkpoint: SE argument feasible?
Phase 2: Preparation
├── Step 4: Complete performance testing
├── Step 5: Prepare device description
├── Step 6: Document SE comparison
├── Step 7: Finalize labeling
└── Checkpoint: All required sections complete?
Phase 3: Submission
├── Step 8: Assemble submission package
├── Step 9: Submit via eSTAR
├── Step 10: Track acknowledgment
└── Checkpoint: Submission accepted?
Phase 4: Review
├── Step 11: Monitor review status
├── Step 12: Respond to AI requests
├── Step 13: Receive decision
└── Verification: SE letter received?
| Section | Content |
|---|---|
| Cover Letter | Submission type, device ID, contact info |
| Form 3514 | CDRH premarket review cover sheet |
| Device Description | Physical description, principles of operation |
| Indications for Use | Form 3881, patient population, use environment |
| SE Comparison | Side-by-side comparison with predicate |
| Performance Testing | Bench, biocompatibility, electrical safety |
| Software Documentation | Level of concern, hazard analysis (IEC 62304) |
| Labeling | IFU, package labels, warnings |
| 510(k) Summary | Public summary of submission |
| Issue | Prevention |
|---|---|
| Missing user fee | Verify payment before submission |
| Incomplete Form 3514 | Review all fields, ensure signature |
| No predicate identified | Confirm K-number in FDA database |
| Inadequate SE comparison | Address all technological characteristics |
Quality System Regulation (21 CFR Part 820) requirements for medical device manufacturers.
| Section | Title | Focus |
|---|---|---|
| 820.20 | Management Responsibility | Quality policy, org structure, management review |
| 820.30 | Design Controls | Input, output, review, verification, validation |
| 820.40 | Document Controls | Approval, distribution, change control |
| 820.50 | Purchasing Controls | Supplier qualification, purchasing data |
| 820.70 | Production Controls | Process validation, environmental controls |
| 820.100 | CAPA | Root cause analysis, corrective actions |
| 820.181 | Device Master Record | Specifications, procedures, acceptance criteria |
Step 1: Design Input
└── Capture user needs, intended use, regulatory requirements
Verification: Inputs reviewed and approved?
Step 2: Design Output
└── Create specifications, drawings, software architecture
Verification: Outputs traceable to inputs?
Step 3: Design Review
└── Conduct reviews at each phase milestone
Verification: Review records with signatures?
Step 4: Design Verification
└── Perform testing against specifications
Verification: All tests pass acceptance criteria?
Step 5: Design Validation
└── Confirm device meets user needs in actual use conditions
Verification: Validation report approved?
Step 6: Design Transfer
└── Release to production with DMR complete
Verification: Transfer checklist complete?
Reference: See qsr_compliance_requirements.md for detailed QSR implementation guidance.
HIPAA requirements for devices that create, store, transmit, or access Protected Health Information (PHI).
| Device Type | HIPAA Applies |
|---|---|
| Standalone diagnostic (no data transmission) | No |
| Connected device transmitting patient data | Yes |
| Device with EHR integration | Yes |
| SaMD storing patient information | Yes |
| Wellness app (no diagnosis) | Only if stores PHI |
Administrative (§164.308)
├── Security officer designation
├── Risk analysis and management
├── Workforce training
├── Incident response procedures
└── Business associate agreements
Physical (§164.310)
├── Facility access controls
├── Workstation security
└── Device disposal procedures
Technical (§164.312)
├── Access control (unique IDs, auto-logoff)
├── Audit controls (logging)
├── Integrity controls (checksums, hashes)
├── Authentication (MFA recommended)
└── Transmission security (TLS 1.2+)
Reference: See hipaa_compliance_framework.md for implementation checklists and BAA templates.
FDA cybersecurity requirements for connected medical devices.
| Element | Description |
|---|---|
| Threat Model | STRIDE analysis, attack trees, trust boundaries |
| Security Controls | Authentication, encryption, access control |
| SBOM | Software Bill of Materials (CycloneDX or SPDX) |
| Security Testing | Penetration testing, vulnerability scanning |
| Vulnerability Plan | Disclosure process, patch management |
Tier 1 (Higher Risk):
Tier 2 (Standard Risk):
Researcher Report
↓
Acknowledgment (48 hours)
↓
Initial Assessment (5 days)
↓
Fix Development
↓
Coordinated Public Disclosure
Reference: See device_cybersecurity_guidance.md for SBOM format examples and threat modeling templates.
| Script | Purpose |
|---|---|
fda_submission_tracker.py | Track 510(k)/PMA/De Novo submission milestones and timelines |
qsr_compliance_checker.py | Assess 21 CFR 820 compliance against project documentation |
hipaa_risk_assessment.py | Evaluate HIPAA safeguards in medical device software |
| File | Content |
|---|---|
fda_submission_guide.md | 510(k), De Novo, PMA submission requirements and checklists |
qsr_compliance_requirements.md | 21 CFR 820 implementation guide with templates |
hipaa_compliance_framework.md | HIPAA Security Rule safeguards and BAA requirements |
device_cybersecurity_guidance.md | FDA cybersecurity requirements, SBOM, threat modeling |
fda_capa_requirements.md | CAPA process, root cause analysis, effectiveness verification |
# Track FDA submission status
python scripts/fda_submission_tracker.py /path/to/project --type 510k
# Assess QSR compliance
python scripts/qsr_compliance_checker.py /path/to/project --section 820.30
# Run HIPAA risk assessment
python scripts/hipaa_risk_assessment.py /path/to/project --category technical
Manage — FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QSR (21 CFR 820) compliance, HIPAA assessments, and device cybersecurity. Use
Use this skill when the task requires fda consultant specialist capabilities.
If this skill fails to produce the expected output: (1) verify input completeness, (2) retry with more specific context, (3) fall back to the parent workflow without this skill.