fda-consultant-specialist

# FDA Consultant Specialist

FDA regulatory consulting for medical device manufacturers covering submission pathways, Quality System Regulation (QSR), HIPAA compliance, and device cybersecurity requirements.

## Table of Contents

- [FDA Pathway Selection](#fda-pathway-selection)
- [510(k) Submission Process](#510k-submission-process)
- [QSR Compliance](#qsr-compliance)
- [HIPAA for Medical Devices](#hipaa-for-medical-devices)
- [Device Cybersecurity](#device-cybersecurity)
- [Resources](#resources)

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## 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 | 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+ |

### Pre-Submission Strategy

1. Identify product code and classification
2. Search 510(k) database for predicates
3. Assess substantial equivalence feasibility
4. Prepare Q-Sub questions for FDA
5. Schedule Pre-Sub meeting if needed

**Reference:** See [fda_submission_guide.md](references/fda_submission_guide.md) for pathway decision matrices and submission requirements.

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## 510(k) Submission Process

### Workflow

```
Phase 1: Planning
├── Step 1: Identify predicate device(s)
├── Step 2: Co...