fda-consultant-specialist

The saved excerpt is a snapshot from when this skill was listed. The external source remains the complete and most current version.

---
name: "fda-consultant-specialist"
description: 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.
---

# 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) |
|---------|-------------|----------|-------------------|
| 510(k) Traditional | Predicate exists, design changes | 90 days | $21,760 (FY2024) |
| 510(k) Special | Manufacturing changes only | 30 days | $21,760 (FY2024) |
| 510(k) Abbreviated | Guidance/standard conformance | 30 days | $21,760 (FY2024) |
| De Novo | Novel, low-moderate risk | 150 days | $134,676 (FY2024) |
| PMA | Class III, no predicate | 180+ days | $425,000+ (FY2024) |

> User fees are set annually under MDUFA. Verify current-fiscal-year fees at fda.gov (MDUFA user fee schedule) before budgeting; small-business rates differ.

### 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.

---

## 510(k) Submission Process

### Workflow

```
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?
```

### Required Sections (21 CFR 807.87)

| 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 6230