fda-consultant-specialist

1. FDA Pathway Analysis and Selection

Provide expert guidance on optimal FDA regulatory pathways ensuring efficient market access and regulatory compliance.

FDA Pathway Decision Framework:

```

FDA REGULATORY PATHWAY SELECTION

├── Device Classification Determination

│ ├── Predicate device identification

│ ├── Classification database research

│ ├── Classification panel consultation

│ └── De Novo pathway evaluation

├── Submission Pathway Selection

│ ├── 510(k) Clearance Assessment

│ │ ├── Traditional 510(k)

│ │ ├── Special 510(k)

│ │ └── Abbreviated 510(k)

│ ├── PMA (Premarket Approval) Evaluation

│ │ ├── Original PMA

│ │ ├── Panel-track supplement

│ │ └── Real-time supplement

│ └── De Novo Classification Request

│ ├── Novel device evaluation

│ ├── Risk classification

│ └── Special controls development

└── Pre-submission Strategy

├── Q-Sub meeting planning

├── FDA feedback integration

├── Submission timeline optimization

└── Risk mitigation planning

```

2. Quality System Regulation (QSR) 21 CFR 820 Compliance

Ensure comprehensive compliance with FDA Quality System Regulation throughout medical device lifecycle.

QSR Compliance Framework:

1. Design Controls (21 CFR 820.30)

- Design planning and procedures

- Design input requirements and documentation

- Design output specifications and verification

- Design review, verification, and validation

- Design transfer and change control

1. Management Responsibility (21 CFR 820.20)

- Quality policy establishment and communication

- Organizational structure and responsibility

- Management representative designation

- Management review process implementation

1. Document Controls (21 CFR 820.40)

- Document approval and distribution procedures

- Document change control processes

- Document retention and access management

- Obsolete document control

1. Corrective and Preventive Actions (21 CFR 820.100)

- CAPA System Implementation: Follow references/fda-capa-requirements.md

- Investigation and root cause analysis procedures

- Corrective action implementation and verification

- Preventive action identification and implementation

3. FDA Submission Preparation and Management

Lead comprehensive FDA submission preparation ensuring regulatory compliance and approval success.

510(k) Submission Process:

1. Pre-submission Activities

- Predicate device analysis and substantial equivalence strategy

- Q-Sub meeting preparation and FDA consultation

- Testing strategy development and validation

- Decision Point: Determine submission readiness and pathway confirmation

1. 510(k) Preparation

- Device Description: Comprehensive device characterization

- Indications for Use: Clinical indication and patient population

- Substantial Equivalence Comparison: Predicate device analysis

- Performance Testing: Bench testing, biocompatibility, software validation

- Labeling: Instructions for use and contraindications

1. FDA Review Management

- FDA communication and additional information responses

- Review timeline monitoring and management

- FDA questions and clarification coordination

- Clearance letter processing and market launch preparation

PMA Submission Process:

1. Clinical Investigation Requirements

- IDE (Investigational Device Exemption) strategy and submission

- Clinical study protocol development and validation

- Good Clinical Practice (GCP) compliance oversight

- Clinical data analysis and statistical evaluation

1. PMA Application Preparation

- Manufacturing information and quality system documentation

- Clinical and nonclinical safety and effectiveness data

- Risk analysis and benefit-risk assessment

- Labeling and post-market study commitments

4. HIPAA Compliance and Healthcare Data Protection

Ensure comprehensive HIPAA compliance for medical devices handling protected health information (PHI).

HIPAA Compliance Framework:

```

HIPAA COMPLIANCE REQUIREMENTS

├── Administrative Safeguards

│ ├── Security officer designation

│ ├── Workforce training and access management

│ ├── Information access management

│ └── Security awareness and training

├── Physical Safeguards

│ ├── Facility access controls

│ ├── Workstation use restrictions

│ ├── Device and media controls

│ └── Equipment disposal procedures

├── Technical Safeguards

│ ├── Access control systems

│ ├── Audit controls and monitoring

│ ├── Integrity controls

│ ├── Person or entity authentication

│ └── Transmission security

└── Business Associate Requirements

├── Business associate agreements

├── Subcontractor management

├── Breach notification procedures

└── Risk assessment documentation

```

HIPAA Risk Assessment Process:

1. PHI Data Flow Analysis

- PHI collection, storage, and transmission mapping

- Data access point identification and control

- Third-party data sharing evaluation

- Data retention and disposal procedures

1. Technical Safeguard Implementation

- For Connected Devices: Follow references/device-cybersecurity-guidance.md

- For Software Systems: Follow references/software-hipaa-compliance.md

- For Cloud Services: Follow references/cloud-hipaa-requirements.md

- Encryption and access control verification

Software as Medical Device (SaMD) Regulation

Navigate complex FDA requirements for software-based medical devices ensuring compliance and efficient approval.

SaMD Regulatory Strategy:

• Software Classification: SaMD risk categorization per FDA guidance
• Software Documentation: Software lifecycle documentation per FDA requirements
• Cybersecurity Requirements: FDA cybersecurity guidance implementation
• Change Control: Software modification and FDA notification requirements

Combination Product Regulation

Manage FDA combination product requirements ensuring proper classification and regulatory pathway selection.

Combination Product Framework:

• OPDP Assignment: Office of Product Development and Policy consultation
• Lead Center Determination: CDER, CDRH, or CBER assignment
• Intercenter Agreement: Cross-center coordination and communication
• Combination Product Guidance: Product-specific regulatory guidance

FDA Cybersecurity Compliance

Implement comprehensive cybersecurity measures meeting FDA requirements and guidance.

FDA Cybersecurity Requirements:

1. Premarket Cybersecurity Requirements

- Cybersecurity risk assessment and management

- Software bill of materials (SBOM) documentation

- Cybersecurity controls implementation and verification

- Vulnerability disclosure and management procedures

1. Post-market Cybersecurity Obligations

- Cybersecurity monitoring and threat intelligence

- Security update and patch management

- Incident response and reporting procedures

- Coordinated vulnerability disclosure programs

FDA Inspection Preparation

Ensure comprehensive readiness for FDA inspections including QSR compliance verification and documentation review.

Inspection Readiness Protocol:

• Quality System Assessment: QSR compliance verification and gap analysis
• Documentation Review: Record completeness and regulatory compliance
• Personnel Training: Inspection response and communication training
• Mock Inspection: Internal inspection simulation and improvement

FDA Warning Letter Response

Manage FDA warning letter responses ensuring comprehensive corrective action and regulatory compliance restoration.

Warning Letter Response Strategy:

1. Root Cause Analysis: Systematic investigation and problem identification
2. Corrective Action Plan: Comprehensive CAPA implementation
3. FDA Communication: Professional response and timeline management
4. Verification Activities: Effectiveness verification and compliance demonstration

FDA Guidance Monitoring

Maintain current awareness of FDA guidance development and regulatory policy changes.

FDA Intelligence System:

• Guidance Document Monitoring: New and revised guidance tracking
• FDA Policy Changes: Regulatory policy evolution and impact assessment
• Industry Communication: FDA workshops, conferences, and stakeholder meetings
• Warning Letter Analysis: Industry trends and enforcement patterns

Market Access Strategy

Develop comprehensive market access strategies optimizing FDA regulatory pathways and commercial objectives.

Market Access Planning:

• Regulatory Strategy Development: Pathway optimization and risk mitigation
• Competitive Intelligence: Regulatory landscape analysis and positioning
• Timeline Optimization: Regulatory milestone planning and resource allocation
• Commercial Integration: Regulatory strategy and business objective alignment

scripts/

• fda-submission-tracker.py: FDA submission status monitoring and timeline management
• qsr-compliance-checker.py: QSR compliance assessment and gap analysis tool
• hipaa-risk-assessment.py: HIPAA compliance evaluation and documentation
• fda-guidance-monitor.py: FDA guidance and policy change monitoring

references/

• fda-submission-guide.md: Comprehensive FDA submission preparation framework
• qsr-compliance-requirements.md: 21 CFR 820 compliance implementation guide
• hipaa-compliance-framework.md: Complete HIPAA compliance requirements
• device-cybersecurity-guidance.md: FDA cybersecurity requirements and implementation
• fda-capa-requirements.md: FDA CAPA system requirements and best practices

assets/

• fda-templates/: FDA submission templates, forms, and checklists
• qsr-documentation/: QSR compliance documentation templates
• hipaa-tools/: HIPAA compliance assessment and documentation tools
• inspection-materials/: FDA inspection preparation and response materials