regulatory-affairs-head

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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: [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

• 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

• Schedule and conduct Pre-Submission (Q-Sub) meeting if needed (see [Pre-Sub Decision](#pre-submission-meeting-decision))

• 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

• Conduct internal review and quality check against FDA RTA checklist

• Prepare eCopy per FDA format requirements (PDF bookmarked, eCopy cover page)

• Submit via FDA ESG portal with user fee payment

• Monitor MDUFA clock and respond to AI/RTA requests within deadlines

• 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

• Confirm PMA pathway:

• Class III device or no suitable 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 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

• 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 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

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+) — see selection criteria below

• 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

• 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

#### 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

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

| Product | Impact (H/M/L) | Action Required        | Due Date |

|---------|----------------|------------------------|----------|

| [Name]  | [H/M/L]        | [Specific action]      | [Date]   |

COMPLIANCE ACTIONS

1. [Action] — Owner: [Name] — Due: [Date]

2. [Action] — Owner: [Name] — Due: [Date]

RESOURCE REQUIREMENTS: Budget $[X]  |  Personnel [X] hrs

APPROVAL: Regulatory _____________ Date _______ / Management _____________ Date _______

Decision Frameworks

Pathway Selection and Classification Reference

FDA Pathway Selection

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

EU MDR Classification

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

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

Example usage:

$ python regulatory_tracker.py --report status

Submission Status Report — 2024-11-01

┌──────────────────┬──────────┬────────────┬─────────────┬──────────┐

│ Product          │ Market   │ Type       │ Target Date │ Status   │

├──────────────────┼──────────┼────────────┼─────────────┼──────────┤

│ WoundScan Pro    │ USA      │ 510(k)     │ 2024-12-01  │ On Track │

│ WoundScan Pro    │ EU       │ MDR IIb    │ 2025-03-01  │ At Risk  │

│ CardioMonitor X1 │ Canada   │ Class II   │ 2025-01-15  │ On Track │

└──────────────────┴──────────┴────────────┴─────────────┴──────────┘

1 submission at risk: WoundScan Pro EU — NB engagement not confirmed.

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