Regulatory Affairs HeadSAFE

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The instruction file, verbatim from the audited commit — this is the text the model reads, and the surface the audit's instruction layer examines. Quoted here so you can judge it without cloning anything.

---
name: "regulatory-affairs-head"
description: Senior Regulatory Affairs Manager for HealthTech and MedTech companies. Prepares FDA 510(k), De Novo, and PMA submission packages; analyzes regulatory pathways for new medical devices; drafts responses to FDA deficiency letters and Notified Body queries; develops CE marking technical documentation under EU MDR 2017/745; coordinates multi-market approval strategies across FDA, EU, Health Canada, PMDA, and NMPA; and maintains regulatory intelligence on evolving standards. Use when users need to plan or execute FDA submissions, navigate 510(k) or PMA approval processes, achieve CE marking, prepare pre-submission meeting materials, write regulatory strategy documents, respond to agency queries, or manage compliance documentation for medical device market access.
triggers:
  - regulatory strategy
  - FDA submission
  - EU MDR
  - 510(k)
  - PMA approval
  - CE marking
  - regulatory pathway
  - market access
  - clinical evidence
  - regulatory intelligence
  - submission planning
  - notified body
---

# Head of Regulatory Affairs

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

---

## Table of Contents

- [Regulatory Strategy Workflow](#regulatory-strategy-workflow)
- [FDA Submission Workflow](#fda-submission-workflow)
- [EU MDR Submission Workflow](#eu-mdr-submission-workflow)
- [Global Market Access Workflow](#global-market-access-workflow)
- [Regulatory Intelligence Workflow](#regulatory-intelligence-workflow)
- [Decision Frameworks](#decision-frameworks)
- [Tools and References](#tools-and-references)

---

## Regulatory Strategy Workflow

Develop regulatory strategy aligned with business objectives and product characteristics.

### Workflow: New Product Regulatory Strategy

1. Gather product information:
   - Intended use and indications
   - Device classification (risk level)
   - Technology platform
   - Target markets and timeline
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:
   - Compare submission types (510(k) vs De Novo vs PMA)
   - Assess predicate device availability
   - Evaluate clinical evidence requirements
4. Develop regulatory timeline with milestones
5. Estimate resource requirements and budget
6. Identify regulatory risks and mitigation strategies
7. Obtain stakeholder alignment and approval
8. **Validation:** Strategy document approved; timeline accepted; resources allocated

### 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 |

### Regulatory Strategy Document Template

```
REGULATORY STRATEGY

Product: [Name]   Version: [X.X]   Date: [Date]

1. PRODUCT OVERVIEW
   Intended use: [One-sentence statement of intended patient population, body site, and clinical purpose]
   Device classification: [Class I / II / III]
   Technology: [Brief description, e.g., "AI-powered wound-imaging software, SaMD"]

2. TARGET MARKETS & TIMELINE
   | Market | Pathway        | Priority | Target Date |
   |--------|----------------|----------|-------------|
   | USA    | 510(k) / PMA   | 1        | Q1 20XX     |
   | EU     | Class [X] MDR  | 2        | Q2 20XX     |

3. REGULATORY PATHWAY RATIONALE
   FDA: [510(k) / De Novo / PMA] — Predicate: [K-number or "none"]
   EU:  Class [X] via [Annex IX / X / XI] — NB: [Name or TBD]
   Rationale: [2–3 sentences on key factors driving pathway choice]

4. CLINICAL EVIDENCE STRATEGY
   Requirements: [Summarize what each market needs, e.g., "510(k): bench + usability; EU Class IIb: PMCF study"]
   Approach: [Literature review / Prospective study / Combination]

5. RISKS AND MITIGATION
   | Risk                         | Prob | Impact | Mitigation                        |
   |------------------------------|------|--------|-----------------------------------|
   | Predicate delisted by FDA    | Low  | High   | Identify secondary predicate now  |
   | NB audit backlog             | Med  | Med    | Engage NB 6 months before target  |

6. RESOURCE REQUIREMENTS
   Budget: $[Amount]   Personnel: [FTEs]   External: [Consultants / CRO]
```

---

## FDA Submission Workflow

Prepare and submit FDA regulatory applications.

### Workflow: 510(k) Submission

1. Confirm 510(k) pathway suitability:
   - Predicate device identified (note K-number, e.g., K213456)
   - Substantial equivalence (SE) argument supportable on intended use and technological characteristics
   - No new intended use or technology concerns triggering De Novo
2. Schedule and conduct Pre-Submission (Q-Sub) meeting if needed (see [Pre-Sub Decision](#pre-submission-meeting-decision))
3. Compile submission package checklist:
   - [ ] Cover letter with device name, product code, and predicate K-number
   - [ ] Section 1: Administrative information (applicant, contact, 510(k) type)
   - [ ] Section 2: Device description — include photos, dimensions, materials list
   - [ ] Section 3: Intended use and indications for use
   - [ ] Section 4: Substantial equivalence comparison table (see example below)
   - [ ] Section 5: Performance testing — protocols, standards cited, pass/fail results
   - [ ] Section 6: Biocompatibility summary (ISO 10993-1 risk assessment, if patient contact)
   - [ ] Section 7: Software documentation (IEC 62304 level, cybersecurity per FDA guidance, if applicable)
   - [ ] Section 8: Labeling — final draft IFU, device label
   - [ ] Section 9: Summary and conclusion
4. Conduct internal

SAFEgrade B · trust 89/100 Nothing in the source contradicts what it says it does. Grade A is reserved for packages that have also passed the behavioural sandbox.

What the source does

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Network

none-observed

Shell

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pinned

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Findings (1)

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Gates applied: no_behavioural_pass.