regulatory-affairs-head

What this skill does

# Head of Regulatory Affairs

Regulatory strategy development, submission management, and global market access for medical device organizations.

---

## Regulatory Strategy Workflow

The agent develops regulatory strategy aligned with business objectives and product characteristics.

### Workflow: New Product Regulatory Strategy

1. **Gather product information** -- collect intended use, device classification (risk level), technology platform, target markets, and timeline from stakeholders.
2. **Identify applicable regulations** per target market:
   - FDA (US): 21 CFR Part 820, 510(k)/PMA/De Novo
   - EU: MDR 2017/745, Notified Body requirements
   - Other markets: Health Canada, PMDA, NMPA, TGA
3. **Determine optimal regulatory pathway** using the pathway selection matrix below -- compare submission types, assess predicate device availability, evaluate clinical evidence requirements.
4. **Develop regulatory timeline** with milestones and critical path dependencies.
5. **Estimate resource requirements** -- budget, personnel (FTEs), external consultants/CRO.
6. **Identify regulatory risks** and define mitigation strategies for each.
7. **Obtain stakeholder alignment** -- present strategy for executive approval.
8. **Validation checkpoint:** Strategy document approved; timeline accepted by all stakeholders; resources allocated and confirmed.

### Regulatory Pathway Selection Matrix

| Factor | 510(k) | De Novo | PMA |
|--------|--------|---------|-----|
| Predicate Available | Yes | No | N/A |
| Risk Level | Low-Moderate | Low-Moderate | High |
| Clinical Data | Usually not required | May be required | Required |
| Review Time | 90 days (MDUFA) | 150 days | 180 days |
| User Fee | ~$22K (2024) | ~$135K | ~$440K |
| Best For | Me-too devices | Novel low-risk | High-risk, novel |

### Example: Regulatory Strategy Output

```
REGULATORY STRATEGY

Product: CardioSense Wearable ECG Monitor
Version: 1.0
Date: 2026-03-12

1. PRODUCT OVERVIEW
   - Intended use: Continuous ECG monitoring for arrhythmia detection
   - Device classification: Class II (FDA), Class IIa (EU MDR)
   - Technology: Single-lead ECG with ML-based AF detection

2. TARGET MARKETS
   | Market | Priority | Timeline    |
   |--------|----------|-------------|
   | USA    | 1        | Q3 2026     |
   | EU     | 2        | Q1 2027     |
   | Canada | 3        | Q2 2027     |

3. REGULATORY PATHWAY
   - FDA: 510(k) — Predicate: AliveCor KardiaMobile (K142743)
   - EU: Class IIa via Annex IX (QMS) + Annex XI Part A (Product)
   - Rationale: Established predicate supports SE argument;
     MDR IIa classification per Rule 10 (active diagnostic)

4. CLINICAL EVIDENCE STRATEGY
   - Requirements: SE comparison + analytical performance data
   - Approach: Literature review for AF detection + bench study

5. RISKS AND MITIGATION
   | Risk                     | Probability | Impact | Mitigation                    |
   |--------------------------|-------------|--------|-------------------------------|
   | FDA requests clinical    | Medium      | High   | Pre-Sub meeting to align      |
   | NB capacity delay        | High        | Medium | Engage NB by Q4 2025         |
   | ML algorithm as SaMD     | Medium      | High   | Follow FDA AI/ML SaMD guidance|
```

---

## FDA Submission Workflow

The agent prepares and submits FDA regulatory applications following established pathways.

### Workflow: 510(k) Submission

1. **Confirm 510(k) pathway suitability** -- verify predicate device identified, substantial equivalence supportable, no new intended use or technology concerns.
2. **Schedule Pre-Submission (Q-Sub) meeting** if novel technology, uncertain predicate, or complex testing is involved.
3. **Compile submission package:**
   - Cover letter and administrative information
   - Device description and intended use
   - Substantial equivalence comparison
   - Performance testing data
   - Biocompatibility (if patient contact, per ISO 10993)
   - Software documentation (if applicable, per IEC 62304)
   - Labeling and IFU
4. **Conduct internal review** -- quality check all sections against FDA checklist.
5. **Prepare eCopy** per current FDA format requirements.
6. **Submit via FDA ESG portal** with user fee payment.
7. **Monitor MDUFA clock** and respond to AI/RTA requests within deadline.
8. **Validation checkpoint:** Submission accepted (RTA complete); MDUFA goal date received; tracking system updated.

### Workflow: PMA Submission

1. **Confirm PMA pathway** -- Class III device or no suitable predicate; clinical data strategy defined.
2. **Complete IDE clinical study** if required -- IDE approval, protocol execution, study report.
3. **Conduct Pre-Submission meeting** with FDA.
4. **Compile PMA submission** -- administrative/device information, manufacturing information, nonclinical studies, clinical studies, labeling.
5. **Submit original PMA** application.
6. **Address FDA questions** and deficiency letters within specified timeframes.
7. **Prepare for FDA facility inspection** -- coordinate with Quality team.
8. **Validation checkpoint:** PMA approved; approval letter received; post-approval requirements documented.

### FDA Submission Timeline

| Milestone | 510(k) | De Novo | PMA |
|-----------|--------|---------|-----|
| Pre-Sub Meeting | Day -90 | Day -90 | Day -120 |
| Submission | Day 0 | Day 0 | Day 0 |
| RTA Review | Day 15 | Day 15 | Day 45 |
| Substantive Review | Days 15-90 | Days 15-150 | Days 45-180 |
| Decision | Day 90 | Day 150 | Day 180 |

### Common FDA Deficiencies

| Category | Common Issues | Prevention |
|----------|---------------|------------|
| Substantial Equivalence | Weak predicate comparison | Strong SE argument upfront |
| Performance Testing | Incomplete test protocols | Follow recognized standards |
| Biocompatibility | Missing endpoints | ISO 10993 risk assessment |
| Software | Inadequate documentation | IEC 62304 compliance |
| Labeling | Inconsistent claims | Early labeling review |

See: [references/fda-submission-guide.md](references/fda-submission-guide.md)

---

## EU MDR Submission Workflow

The agent achieves CE marking under EU MDR 2017/745.

### Workflow: MDR Technical Documentation

1. **Confirm device classification** per MDR Annex VIII rules.
2. **Select conformity assessment route** based on class:
   - Class I: Self-declaration
   - Class IIa/IIb: Notified Body involvement
   - Class III: Full NB assessment
3. **Select and engage Notified Body** (for Class IIa+) -- evaluate scope, capacity, experience, and timeline.
4. **Compile Technical Documentation** per Annex II:
   - Device description and specifications
   - Design and manufacturing information
   - GSPR checklist (General Safety and Performance Requirements)
   - Benefit-risk analysis and risk management (ISO 14971)
   - Clinical evaluation per Annex XIV
   - Post-market surveillance plan
5. **Establish and document QMS** per ISO 13485.
6. **Submit application to Notified Body.**
7. **Address NB questions** and coordinate audit logistics.
8. **Validation checkpoint:** CE certificate issued; Declaration of Conformity signed; EUDAMED registration complete.

### Clinical Evidence Requirements by Class

| Class | Clinical Requirement | Documentation |
|-------|---------------------|---------------|
| I | Clinical evaluation (CE) | CE report |
| IIa | CE with literature focus | CE report + PMCF plan |
| IIb | CE with clinical data | CE report + PMCF + clinical study (some) |
| III | CE with clinical investigation | CE report + PMCF + clinical investigation |

### Notified Body Selection Criteria

| Criterion | Consideration |
|-----------|---------------|
| Scope | Device category expertise |
| Capacity | Availability and review timeline |
| Experience | Track record in your technology |
| Geography | Proximity for audits |
| Cost | Fee structure transparency |
| Communication | Responsiveness and clarity |

See: [references/eu-mdr-submission-guide.md](references/eu-mdr-submission-guide.md)

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