FDA regulatory consulting — 510(k)/PMA/De Novo pathway guidance, QSR (21 CFR 820) compliance, HIPAA assessments, and device cybersecurity.
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FDA regulatory consulting for medical device manufacturers covering submission pathways, QSR, HIPAA, and device cybersecurity.
Predicate device exists?
├── YES → Substantially equivalent?
│ ├── YES → 510(k) (Traditional / Special / Abbreviated)
│ └── 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 |
| De Novo | Novel, low-moderate risk | 150 days | $134,676 |
| PMA | Class III, no predicate | 180+ days | $425,000+ |
For pathway decision matrices and Pre-Submission strategy, see references/fda_submission_guide.md.
For required sections (21 CFR 807.87) and common RTA issues, see references/fda_submission_guide.md.
| Section | Title | Focus |
|---|---|---|
| 820.20 | Management Responsibility | Quality policy, management review |
| 820.30 | Design Controls | Input, output, V&V, transfer |
| 820.40 | Document Controls | Approval, distribution, changes |
| 820.100 | CAPA | Root cause, corrective actions |
For design controls workflow and CAPA process details, see references/qsr_compliance_requirements.md.
Applies to devices that create, store, transmit, or access PHI. Requires:
For applicability matrix, safeguard details, and risk assessment steps, see references/hipaa_compliance_framework.md.
| 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 |
For device tier classification, postmarket obligations, and vulnerability disclosure process, see references/device_cybersecurity_guidance.md.
| Script | Purpose |
|---|---|
fda_submission_tracker.py | Track submission milestones and timelines |
qsr_compliance_checker.py | Assess 21 CFR 820 compliance |
hipaa_risk_assessment.py | Evaluate HIPAA safeguards |
| Document | Content |
|---|---|
| fda_submission_guide.md | Submission requirements and checklists |
| qsr_compliance_requirements.md | 21 CFR 820 implementation guide |
| hipaa_compliance_framework.md | HIPAA Security Rule and BAA requirements |
| device_cybersecurity_guidance.md | FDA cybersecurity, SBOM, threat modeling |
| fda_capa_requirements.md | CAPA process and root cause analysis |
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