Regulatory Affairs Head

What This Skill Does

This skill supports the Head of Regulatory Affairs in developing regulatory strategies, managing submissions, and achieving global market access for medical devices. It provides workflows and frameworks for navigating regulatory landscapes. It helps ensure compliance and efficient market entry.

When to Use

• Developing a regulatory strategy.
• Managing FDA submissions.
• Managing EU MDR submissions.
• Achieving global market access.
• Conducting regulatory intelligence.
• Selecting regulatory pathways.

Key Features

• Offers a regulatory strategy workflow.
• Provides guidance on FDA submissions.
• Supports EU MDR submissions.
• Facilitates global market access.
• Includes a regulatory intelligence workflow.
• Presents a regulatory pathway selection matrix.

Manual Installation

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

Regulatory Strategy Document Template

REGULATORY STRATEGY

Product: [Name] Version: [X.X] Date: [Date]

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"]

TARGET MARKETS & TIMELINE

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]

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]

RISKS AND MITIGATION

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) 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

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

Common FDA Deficiencies and Prevention