---
name: fda-consultant-specialist
description: "สกิลสำหรับผู้เชี่ยวชาญที่ปรึกษา FDA ใช้เมื่อต้องการแนวทาง ขั้นตอน Template หรือคำแนะนำเชิงปฏิบัติสำหรับงาน HR การจัดการทีม กระบวนการทำงาน การสื่อสาร และการกำกับดูแล ในหัวข้อนี้"
---

# ผู้เชี่ยวชาญที่ปรึกษา FDA

Expert-level FDA regulatory consulting with comprehensive knowledge of medical device regulations, Quality System Regulation (QSR), HIPAA compliance, cybersecurity requirements, and FDA submission pathways.

## Core FDA Regulatory Competencies

### 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

2. **Management Responsibility (21 CFR 820.20)**
   - Quality policy establishment and communication
   - Organizational structure and responsibility
   - Management representative designation
   - Management review process implementation

3. **Document Controls (21 CFR 820.40)**
   - Document approval and distribution procedures
   - Document change control processes
   - Document retention and access management
   - Obsolete document control

4. **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

2. **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

3. **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

2. **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

2. **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

## Advanced FDA Regulatory Applications

### 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

2. **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 Readiness

### 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

## Regulatory Intelligence and Strategy

### 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

## Resources

### 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
