Head of Regulatory Affairs

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

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Table of Contents

• - Regulatory Strategy Workflow
• FDA Submission Workflow
• EU MDR Submission Workflow
• Global Market Access Workflow
• Regulatory Intelligence Workflow
• Decision Frameworks
• Tools and References

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Regulatory Strategy Workflow

Develop regulatory strategy aligned with business objectives and product characteristics.

Workflow: New Product Regulatory Strategy

1. 1. Gather product information:

- Intended use and indications - Device classification (risk level) - Technology platform - Target markets and timeline

1. 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

1. 3. Determine optimal regulatory pathway:

- Compare submission types (510(k) vs De Novo vs PMA) - Assess predicate device availability - Evaluate clinical evidence requirements

1. 4. Develop regulatory timeline with milestones
2. Estimate resource requirements and budget
3. Identify regulatory risks and mitigation strategies
4. Obtain stakeholder alignment and approval
5. 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

CODEBLOCK0

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FDA Submission Workflow

Prepare and submit FDA regulatory applications.

Workflow: 510(k) Submission

1. 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

1. 2. Schedule and conduct Pre-Submission (Q-Sub) meeting if needed (see Pre-Sub Decision)
2. 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

1. 4. Conduct internal review and quality check against FDA RTA checklist
2. Prepare eCopy per FDA format requirements (PDF bookmarked, eCopy cover page)
3. Submit via FDA ESG portal with user fee payment
4. Monitor MDUFA clock and respond to AI/RTA requests within deadlines
5. Validation: Submission accepted; MDUFA date received; tracking system updated

Substantial Equivalence Comparison Example

Characteristic	Predicate (K213456)	Subject Device	Same?	Notes
Intended use	Wound measurement	Wound measurement	✓	Identical
Technology

2D camera | 2D + AI analysis | ✗ | New TC; address below | | Energy type | Non-energized | Non-energized | ✓ | | | Patient contact | No | No | ✓ | | | SE conclusion | New TC does not raise new safety/effectiveness questions; bench data demonstrates equivalent accuracy (±2mm vs ±3mm predicate) |

Workflow: PMA Submission

1. 1. Confirm PMA pathway:

- Class III device or no suitable predicate - Clinical data strategy defined

1. 2. Complete IDE clinical study if required:

- IDE approval - Clinical protocol execution - Study report completion

1. 3. Conduct Pre-Submission meeting
2. Compile PMA submission checklist:

- [ ] Volume I: Administrative, device description, manufacturing - [ ] Volume II: Nonclinical studies (bench, animal, biocompatibility) - [ ] Volume III: Clinical studies (IDE protocol, data, statistical analysis) - [ ] Volume IV: Labeling - [ ] Volume V: Manufacturing information, sterilization

1. 5. Submit original PMA application
2. Address FDA questions and deficiencies
3. Prepare for FDA facility inspection
4. Validation: 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 and Prevention

Category	Common Issues	Prevention
Substantial Equivalence	Weak predicate comparison; no performance data	Build SE table with data column; cite recognized standards
Performance Testing

Incomplete protocols; missing worst-case rationale | Follow FDA-recognized standards; document worst-case justification | | Biocompatibility | Missing endpoints; no ISO 10993-1 risk assessment | Complete ISO 10993-1 matrix before testing | | Software | Inadequate hazard analysis; no cybersecurity bill of materials | IEC 62304 compliance + FDA cybersecurity guidance checklist | | Labeling | Inconsistent claims vs. IFU; missing symbols standard | Cross-check label against IFU; cite ISO 15223-1 for symbols |

See: references/fda-submission-guide.md

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EU MDR Submission Workflow

Achieve CE marking under EU MDR 2017/745.

Workflow: MDR Technical Documentation

1. 1. Confirm device classification per MDR Annex VIII
2. Select conformity assessment route based on class:

- Class I: Self-declaration - Class IIa/IIb: Notified Body involvement - Class III: Full NB assessment

1. 3. Select and engage Notified Body (for Class IIa+) — see selection criteria below
2. Compile Technical Documentation per Annex II checklist:

- [ ] Annex II §1: Device description, intended purpose, UDI - [ ] Annex II §2: Design and manufacturing information (drawings, BoM, process flows) - [ ] Annex II §3: GSPR checklist — each requirement mapped to evidence (standard, test report, or justification) - [ ] Annex II §4: Benefit-risk analysis and risk management file (ISO 14971) - [ ] Annex II §5: Product verification and validation (test reports) - [ ] Annex II §6: Post-market surveillance plan - [ ] Annex XIV: Clinical evaluation report (CER) — literature, clinical data, equivalence justification

1. 5. Establish and document QMS per ISO 13485
2. Submit application to Notified Body
3. Address NB questions and coordinate audit
4. Validation: CE certificate issued; Declaration of Conformity signed; EUDAMED registration complete

GSPR Checklist Row Example

GSPR Ref	Requirement	Standard / Guidance	Evidence Document	Status
Annex I §1	Safe design and manufacture	ISO 14971:2019	Risk Management File v2.1	Complete
Annex I §11.1

Devices with measuring function ±accuracy | EN ISO 15223-1 | Performance Test Report PT-003 | Complete | | Annex I §17 | Cybersecurity | MDCG 2019-16 | Cybersecurity Assessment CS-001 | In progress |

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

• - Scope: Designated for your specific device category
• Capacity: Confirmed availability within target timeline
• Experience: Track record with your technology type
• Geography: Proximity for on-site audits
• Cost: Fee structure transparency
• Communication: Responsiveness and query turnaround

See: references/eu-mdr-submission-guide.md

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Global Market Access Workflow

Coordinate regulatory approvals across international markets.

Workflow: Multi-Market Submission Strategy

1. 1. Define target markets based on business priorities
2. Sequence markets for efficient evidence leverage:

- Phase 1: FDA + EU (reference markets) - Phase 2: Recognition markets (Canada, Australia) - Phase 3: Major markets (Japan, China) - Phase 4: Emerging markets

1. 3. Identify local requirements per market:

- Clinical data acceptability - Local agent/representative needs - Language and labeling requirements

1. 4. Develop master technical file with localization plan
2. Establish in-country regulatory support
3. Execute parallel or sequential submissions
4. Track approvals and coordinate launches
5. Validation: All target market approvals obtained; registration database updated

Market Priority Matrix

Market	Size	Complexity	Recognition	Priority
USA	Large	High	N/A	1
EU

Large | High | N/A | 1–2 | | Canada | Medium | Medium | MDSAP | 2 | | Australia | Medium | Low | EU accepted | 2 | | Japan | Large | High | Local clinical | 3 | | China | Large | Very High | Local testing | 3 | | Brazil | Medium | High | GMP inspection | 3–4 |

Documentation Efficiency Strategy

Document Type	Single Source	Localization Required
Technical file core	Yes	Format adaptation
Risk management

Yes | None | | Clinical data | Yes | Bridging assessment | | QMS certificate | Yes (ISO 13485) | Market-specific audit | | Labeling | Master label | Translation, local requirements | | IFU | Master content | Translation, local symbols |

See: references/global-regulatory-pathways.md

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Regulatory Intelligence Workflow

Monitor and respond to regulatory changes affecting product portfolio.

Workflow: Regulatory Change Management

1. 1. Monitor regulatory sources:

- FDA Federal Register, guidance documents - EU Official Journal, MDCG guidance - Notified Body communications - Industry associations (AdvaMed, MedTech Europe)

1. 2. Assess relevance to product portfolio
2. Evaluate impact:

- Timeline to compliance - Resource requirements - Product changes needed

1. 4. Develop compliance action plan
2. Communicate to affected stakeholders
3. Implement required changes
4. Document compliance status
5. Validation: Compliance action plan approved; changes implemented on schedule

Regulatory Monitoring Sources

Source	Type	Frequency
FDA Federal Register	Regulations, guidance	Daily
FDA Device Database

510(k), PMA, recalls | Weekly | | EU Official Journal | MDR/IVDR updates | Weekly | | MDCG Guidance | EU implementation | As published | | ISO/IEC | Standards updates | Quarterly | | Notified Body | Audit findings, trends | Per interaction |

Impact Assessment Template

CODEBLOCK1

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Decision Frameworks

Pathway Selection and Classification Reference

FDA Pathway Selection

CODEBLOCK2

EU MDR Classification

CODEBLOCK3

Pre-Submission Meeting Decision

Factor	Schedule Pre-Sub	Skip Pre-Sub
Novel Technology	✓
New Intended Use

✓ | | | Complex Testing | ✓ | | | Uncertain Predicate | ✓ | | | Clinical Data Needed | ✓ | | | Well-established | | ✓ | | Clear Predicate | | ✓ | | Standard Testing | | ✓ |

Regulatory Escalation Criteria

Situation	Escalation Level	Action
Submission rejection	VP Regulatory	Root cause analysis, strategy revision
Major deficiency

Director | Cross-functional response team | | Timeline at risk | Management | Resource reallocation review | | Regulatory change | VP Regulatory | Portfolio impact assessment | | Safety signal | Executive | Immediate containment and reporting |

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Tools and References

Scripts

Tool	Purpose	Usage
regulatory_tracker.py	Track submission status and timelines	INLINECODE0

Regulatory Tracker Features:

• - Track multiple submissions across markets
• Monitor status and target dates
• Identify overdue submissions
• Generate status reports

Example usage:
CODEBLOCK4

References

Document	Content
fda-submission-guide.md	FDA pathways, requirements, review process
eu-mdr-submission-guide.md

MDR classification, technical documentation, clinical evidence | | global-regulatory-pathways.md | Canada, Japan, China, Australia, Brazil requirements | | iso-regulatory-requirements.md | ISO 13485, 14971, 10993, IEC 62304, 62366 requirements |

Key Performance Indicators

KPI	Target	Calculation
First-time approval rate	>85%	(Approved without major deficiency / Total submitted) × 100
On-time submission

>90% | (Submitted by target date / Total submissions) × 100 | | Review cycle compliance | >95% | (Responses within deadline / Total requests) × 100 | | Regulatory hold time | <20% | (Days on hold / Total review days) × 100 |

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Related Skills

Skill	Integration Point
mdr-745-specialist	Detailed EU MDR technical requirements
fda-consultant-specialist

FDA submission deep expertise | | quality-manager-qms-iso13485 | QMS for regulatory compliance | | risk-management-specialist | ISO 14971 risk management |