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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 |
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
| Product | Impact | Action Required | Timeline |
|---------|--------|-----------------|----------|
| [Name] | [H/M/L]| [Description] | [Date] |
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
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 |
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