Regulatory Affairs Head

Head of Regulatory Affairs

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

Clarify First

Before developing the regulatory strategy, confirm these inputs. If any is unknown or vague, ASK — do not assume:

• Device classification and intended use — risk level and what the device does (drives the pathway: 510(k)/De Novo/PMA and MDR class)
• Target markets — US, EU, Canada, Japan, China… (determines which regulations apply and the submission sequencing)
• Predicate availability — whether a suitable predicate exists or the device is novel (selects 510(k) vs De Novo/PMA)

Stop rule: ask only the 2-3 that most change the output. If the user says "just draft it," proceed and list your assumptions at the top of the strategy.

Regulatory Strategy Workflow

The agent develops regulatory strategy aligned with business objectives and product characteristics.

Workflow: New Product Regulatory Strategy

1. Gather product information -- collect intended use, device classification (risk level), technology platform, target markets, and timeline from stakeholders.
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 using the pathway selection matrix below -- compare submission types, assess predicate device availability, evaluate clinical evidence requirements.
4. Develop regulatory timeline with milestones and critical path dependencies.
5. Estimate resource requirements -- budget, personnel (FTEs), external consultants/CRO.
6. Identify regulatory risks and define mitigation strategies for each.
7. Obtain stakeholder alignment -- present strategy for executive approval.
8. Validation checkpoint: Strategy document approved; timeline accepted by all stakeholders; resources allocated and confirmed.

Regulatory Pathway Selection Matrix

Example: Regulatory Strategy Output

REGULATORY STRATEGY

Product: CardioSense Wearable ECG Monitor
Version: 1.0
Date: 2026-03-12

1. PRODUCT OVERVIEW
   - Intended use: Continuous ECG monitoring for arrhythmia detection
   - Device classification: Class II (FDA), Class IIa (EU MDR)
   - Technology: Single-lead ECG with ML-based AF detection

2. TARGET MARKETS
   | Market | Priority | Timeline    |
   |--------|----------|-------------|
   | USA    | 1        | Q3 2026     |
   | EU     | 2        | Q1 2027     |
   | Canada | 3        | Q2 2027     |

3. REGULATORY PATHWAY
   - FDA: 510(k) — Predicate: AliveCor KardiaMobile (K142743)
   - EU: Class IIa via Annex IX (QMS) + Annex XI Part A (Product)
   - Rationale: Established predicate supports SE argument;
     MDR IIa classification per Rule 10 (active diagnostic)

4. CLINICAL EVIDENCE STRATEGY
   - Requirements: SE comparison + analytical performance data
   - Approach: Literature review for AF detection + bench study

5. RISKS AND MITIGATION
   | Risk                     | Probability | Impact | Mitigation                    |
   |--------------------------|-------------|--------|-------------------------------|
   | FDA requests clinical    | Medium      | High   | Pre-Sub meeting to align      |
   | NB capacity delay        | High        | Medium | Engage NB by Q4 2025         |
   | ML algorithm as SaMD     | Medium      | High   | Follow FDA AI/ML SaMD guidance|

FDA Submission Workflow

The agent prepares and submits FDA regulatory applications following established pathways.

Workflow: 510(k) Submission

1. Confirm 510(k) pathway suitability -- verify predicate device identified, substantial equivalence supportable, no new intended use or technology concerns.
2. Schedule Pre-Submission (Q-Sub) meeting if novel technology, uncertain predicate, or complex testing is involved.
3. Compile submission package:
   • Cover letter and administrative information
   • Device description and intended use
   • Substantial equivalence comparison
   • Performance testing data
   • Biocompatibility (if patient contact, per ISO 10993)
   • Software documentation (if applicable, per IEC 62304)
   • Labeling and IFU
4. Conduct internal review -- quality check all sections against FDA checklist.
5. Prepare eCopy per current FDA format requirements.
6. Submit via FDA ESG portal with user fee payment.
7. Monitor MDUFA clock and respond to AI/RTA requests within deadline.
8. Validation checkpoint: Submission accepted (RTA complete); MDUFA goal date received; tracking system updated.

Workflow: PMA Submission

1. Confirm PMA pathway -- Class III device or no suitable predicate; clinical data strategy defined.
2. Complete IDE clinical study if required -- IDE approval, protocol execution, study report.
3. Conduct Pre-Submission meeting with FDA.
4. Compile PMA submission -- administrative/device information, manufacturing information, nonclinical studies, clinical studies, labeling.
5. Submit original PMA application.
6. Address FDA questions and deficiency letters within specified timeframes.
7. Prepare for FDA facility inspection -- coordinate with Quality team.
8. Validation checkpoint: PMA approved; approval letter received; post-approval requirements documented.

FDA Submission Timeline

Common FDA Deficiencies

See: references/fda-submission-guide.md

EU MDR Submission Workflow

The agent achieves CE marking under EU MDR 2017/745.

Workflow: MDR Technical Documentation

1. Confirm device classification per MDR Annex VIII rules.
2. Select conformity assessment route based on class:
   • Class I: Self-declaration
   • Class IIa/IIb: Notified Body involvement
   • Class III: Full NB assessment
3. Select and engage Notified Body (for Class IIa+) -- evaluate scope, capacity, experience, and timeline.
4. Compile Technical Documentation per Annex II:
   • Device description and specifications
   • Design and manufacturing information
   • GSPR checklist (General Safety and Performance Requirements)
   • Benefit-risk analysis and risk management (ISO 14971)
   • Clinical evaluation per Annex XIV
   • Post-market surveillance plan
5. Establish and document QMS per ISO 13485.
6. Submit application to Notified Body.
7. Address NB questions and coordinate audit logistics.
8. Validation checkpoint: CE certificate issued; Declaration of Conformity signed; EUDAMED registration complete.

Clinical Evidence Requirements by Class

Notified Body Selection Criteria

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

Global Market Access Workflow

The agent coordinates regulatory approvals across international markets.

Workflow: Multi-Market Submission Strategy

1. Define target markets based on business priorities and revenue projections.
2. Sequence markets for efficient evidence leverage:
   • Phase 1: FDA + EU (reference markets)
   • Phase 2: Recognition markets (Canada via MDSAP, Australia via TGA)
   • Phase 3: Major markets (Japan PMDA, China NMPA)
   • Phase 4: Emerging markets
3. Identify local requirements per market -- clinical data acceptability, local agent/representative needs, language and labeling requirements.
4. Develop master technical file with localization plan.
5. Establish in-country regulatory support.
6. Execute parallel or sequential submissions per sequencing strategy.
7. Track approvals and coordinate product launches.
8. Validation checkpoint: All target market approvals obtained; registration database updated; launch dates confirmed.

Market Priority Matrix

See: references/global-regulatory-pathways.md

Regulatory Intelligence Workflow

The agent monitors and responds to regulatory changes affecting the product portfolio.

Workflow: Regulatory Change Management

1. Monitor regulatory sources -- FDA Federal Register, EU Official Journal, MDCG guidance, Notified Body communications, industry associations (AdvaMed, MedTech Europe).
2. Assess relevance to current product portfolio and pipeline.
3. Evaluate impact -- timeline to compliance, resource requirements, product changes needed.
4. Develop compliance action plan with owners and deadlines.
5. Communicate to affected stakeholders across functions.
6. Implement required changes within established timelines.
7. Document compliance status for management review and audit readiness.
8. Validation checkpoint: Compliance action plan approved; changes implemented on schedule; no gaps at next audit.

Regulatory Monitoring Sources

Decision Frameworks

Pathway Selection Decision Tree

Is predicate device available?
            |
        Yes-+-No
         |     |
         v     v
    Is device   Is risk level
    substantially  Low-Moderate?
    equivalent?       |
         |        Yes-+-No
     Yes-+-No      |     |
      |     |      v     v
      v     v   De Novo  PMA
    510(k)  Consider      required
           De Novo
           or PMA

Pre-Submission Meeting Decision

Regulatory Escalation Criteria