Head of Regulatory Affairs

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

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

Regulatory Strategy Workflow

Develop regulatory strategy aligned with business objectives and product characteristics.

Workflow: New Product Regulatory Strategy

• Gather product information:

• Intended use and indications

• Device classification (risk level)

• Technology platform

• Target markets and timeline

• 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

• Determine optimal regulatory pathway:

• Compare submission types (510(k) vs De Novo vs PMA)

• Assess predicate device availability

• Evaluate clinical evidence requirements

• Develop regulatory timeline with milestones

• Estimate resource requirements and budget

• Identify regulatory risks and mitigation strategies

• Obtain stakeholder alignment and approval

• 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: [Statement]
   • Device classification: [Class I/II/III]
   • Technology: [Description]

2. TARGET MARKETS

   Market	Priority	Timeline
   USA	1	Q1 20XX
   EU	2	Q2 20XX

3. REGULATORY PATHWAY

   • FDA: [510(k) / De Novo / PMA]
   • EU: [Class] via [Conformity route]
   • Rationale: [Justification]

4. CLINICAL EVIDENCE STRATEGY

   • Requirements: [Summary]
   • Approach: [Literature / Study / Both]

5. TIMELINE AND MILESTONES [Gantt or milestone table]

6. RISKS AND MITIGATION

   Risk	Probability	Impact	Mitigation

7. RESOURCE REQUIREMENTS

   • Budget: $[Amount]
   • Personnel: [FTEs]
   • External support: [Consultants, CRO]

FDA Submission Workflow

Prepare and submit FDA regulatory applications.

Workflow: 510(k) Submission

• Confirm 510(k) pathway suitability:

• Predicate device identified

• Substantial equivalence supportable

• No new intended use or technology concerns

• Schedule and conduct Pre-Submission (Q-Sub) meeting if needed

• Compile submission package:

• Cover letter and administrative information

• Device description and intended use

• Substantial equivalence comparison

• Performance testing data

• Biocompatibility (if patient contact)

• Software documentation (if applicable)

• Labeling and IFU

• Conduct internal review and quality check

• Prepare eCopy per FDA format requirements

• Submit via FDA ESG portal with user fee payment

• Monitor MDUFA clock and respond to AI/RTA requests

• Validation: Submission accepted; MDUFA date received; tracking system updated

Workflow: PMA Submission

• Confirm PMA pathway:

• Class III device or no predicate

• Clinical data strategy defined

• Complete IDE clinical study if required:

• IDE approval

• Clinical protocol execution

• Study report completion

• Conduct Pre-Submission meeting

• Compile PMA submission:

• Administrative and device information

• Manufacturing information

• Nonclinical studies

• Clinical studies

• Labeling

• Submit original PMA application

• Address FDA questions and deficiencies

• Prepare for FDA facility inspection

• 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

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

EU MDR Submission Workflow

Achieve CE marking under EU MDR 2017/745.

Workflow: MDR Technical Documentation

• Confirm device classification per MDR Annex VIII

• Select conformity assessment route based on class:

• Class I: Self-declaration

• Class IIa/IIb: Notified Body involvement

• Class III: Full NB assessment

• Select and engage Notified Body (for Class IIa+)

• Compile Technical Documentation per Annex II:

• Device description and specifications

• Design and manufacturing information

• General Safety and Performance Requirements (GSPR) checklist

• Benefit-risk analysis and risk management

• Clinical evaluation per Annex XIV

• Post-market surveillance plan

• Establish and document QMS per ISO 13485

• Submit application to Notified Body

• Address NB questions and coordinate audit

• Validation: CE certificate issued; Declaration of Conformity signed; EUDAMED registration complete

MDR Classification Decision Tree

Is the device active? │ Yes─┴─No │ │ ▼ ▼ Is it an Does it contact implant? the body? │ │ Yes─┴─No Yes─┴─No │ │ │ │ ▼ ▼ ▼ ▼ III IIb Check Class I contact (measuring/ type sterile if and applicable) duration

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

Global Market Access Workflow

Coordinate regulatory approvals across international markets.

Workflow: Multi-Market Submission Strategy

• Define target markets based on business priorities

• 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

• Identify local requirements per market:

• Clinical data acceptability

• Local agent/representative needs

• Language and labeling requirements

• Develop master technical file with localization plan

• Establish in-country regulatory support

• Execute parallel or sequential submissions

• Track approvals and coordinate launches

• 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

Regulatory Intelligence Workflow

Monitor and respond to regulatory changes affecting product portfolio.

Workflow: Regulatory Change Management

• Monitor regulatory sources:

• FDA Federal Register, guidance documents

• EU Official Journal, MDCG guidance

• Notified Body communications

• Industry associations (AdvaMed, MedTech Europe)

• Assess relevance to product portfolio

• Evaluate impact:

• Timeline to compliance

• Resource requirements

• Product changes needed

• Develop compliance action plan

• Communicate to affected stakeholders

• Implement required changes

• Document compliance status

• 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

REGULATORY CHANGE IMPACT ASSESSMENT

Change: [Description] Source: [Regulation/Guidance] Effective Date: [Date] Assessment Date: [Date] Assessed By: [Name]

AFFECTED PRODUCTS

COMPLIANCE ACTIONS

1. [Action 1] - Owner: [Name] - Due: [Date]
2. [Action 2] - Owner: [Name] - Due: [Date]

RESOURCE REQUIREMENTS

• Budget: $[Amount]
• Personnel: [Hours/FTEs]

APPROVAL Regulatory: _________________ Date: _______ Management: _________________ Date: _______

Decision Frameworks

Pathway Selection Decision Tree

Is predicate device available? │ Yes─┴─No │ │ ▼ ▼ Is device Is risk level substantially Low-Moderate? equivalent? │ │ Yes─┴─No Yes─┴─No │ │ │ │ ▼ ▼ ▼ ▼ De Novo PMA 510(k) Consider required De Novo or PMA

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

Tools and References

Scripts

Tool Purpose Usage

regulatory_tracker.py Track submission status and timelines python regulatory_tracker.py

Regulatory Tracker Features:

• Track multiple submissions across markets

• Monitor status and target dates

• Identify overdue submissions

• Generate status reports

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

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