[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"skill:01M6AF1R1Q03WHZ7GWWMNF5CJP":3,"skill-same:01M6AF1R1Q03WHZ7GWWMNF5CJP":91},{"skillNo":4,"name":5,"nameZh":6,"description":7,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":16,"categories":17,"keywords":23,"publishedAt":44,"linkOnly":45,"markdownContent":46,"markdownBody":47,"frontMatter":48,"refName":49,"commitSha":50,"skillDirectory":51,"forksCount":52,"repositoryHtmlUrl":53,"repositoryHomepageUrl":54,"ownerHtmlUrl":55,"ownerBlogUrl":56,"ownerDescription":57,"updatedAt":58,"install":59,"resources":72},"01M6AF1R1Q03WHZ7GWWMNF5CJP","fda-consultant-specialist",null,"Senior FDA consultant and specialist for medical device companies including HIPAA compliance and requirement management. Provides FDA pathway expertise, QSR compliance, cybersecurity guidance, and regulatory submission support. Use for FDA submission planning, QSR compliance assessments, HIPAA evaluations, and FDA regulatory strategy development.","davila7\u002Fclaude-code-templates","davila7","https:\u002F\u002Favatars.githubusercontent.com\u002Fu\u002F6216945?v=4","01M6ADEWWFPS191NFM0Y1EX1JH","Daniel Avila","01M6ADJHGM78PHQRD3XZTFDVKK",33481,"MIT","https:\u002F\u002Fgithub.com\u002Fdavila7\u002Fclaude-code-templates\u002Fblob\u002Fmain\u002Fcli-tool\u002Fcomponents\u002Fskills\u002Fenterprise-communication\u002Ffda-consultant-specialist\u002FSKILL.md",[18],{"categoryNo":19,"categoryName":20,"taxonomyType":21,"taxonomyTypeDesc":22},"01JBSEEDCAT000000000000037","律师与法务","PROFESSION","适用职业",[24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43],"specialist","fda consultant specialist","consultant","fda","senior","cybersecurity","submission","expertise","for","regulatory submission","pathway","medical","regulatory","use","strategy","hipaa","compliance","planning","development","support","2026-11-10 10:12:30",false,"---\nname: fda-consultant-specialist\ndescription: Senior FDA consultant and specialist for medical device companies including HIPAA compliance and requirement management. Provides FDA pathway expertise, QSR compliance, cybersecurity guidance, and regulatory submission support. Use for FDA submission planning, QSR compliance assessments, HIPAA evaluations, and FDA regulatory strategy development.\n---\n\n# Senior FDA Consultant and Specialist\n\nExpert-level FDA regulatory consulting with comprehensive knowledge of medical device regulations, Quality System Regulation (QSR), HIPAA compliance, cybersecurity requirements, and FDA submission pathways.\n\n## Core FDA Regulatory Competencies\n\n### 1. FDA Pathway Analysis and Selection\nProvide expert guidance on optimal FDA regulatory pathways ensuring efficient market access and regulatory compliance.\n\n**FDA Pathway Decision Framework:**\n```\nFDA REGULATORY PATHWAY SELECTION\n├── Device Classification Determination\n│   ├── Predicate device identification\n│   ├── Classification database research\n│   ├── Classification panel consultation\n│   └── De Novo pathway evaluation\n├── Submission Pathway Selection\n│   ├── 510(k) Clearance Assessment\n│   │   ├── Traditional 510(k)\n│   │   ├── Special 510(k)\n│   │   └── Abbreviated 510(k)\n│   ├── PMA (Premarket Approval) Evaluation\n│   │   ├── Original PMA\n│   │   ├── Panel-track supplement\n│   │   └── Real-time supplement\n│   └── De Novo Classification Request\n│       ├── Novel device evaluation\n│       ├── Risk classification\n│       └── Special controls development\n└── Pre-submission Strategy\n    ├── Q-Sub meeting planning\n    ├── FDA feedback integration\n    ├── Submission timeline optimization\n    └── Risk mitigation planning\n```\n\n### 2. Quality System Regulation (QSR) 21 CFR 820 Compliance\nEnsure comprehensive compliance with FDA Quality System Regulation throughout medical device lifecycle.\n\n**QSR Compliance Framework:**\n1. **Design Controls (21 CFR 820.30)**\n   - Design planning and procedures\n   - Design input requirements and documentation\n   - Design output specifications and verification\n   - Design review, verification, and validation\n   - Design transfer and change control\n\n2. **Management Responsibility (21 CFR 820.20)**\n   - Quality policy establishment and communication\n   - Organizational structure and responsibility\n   - Management representative designation\n   - Management review process implementation\n\n3. **Document Controls (21 CFR 820.40)**\n   - Document approval and distribution procedures\n   - Document change control processes\n   - Document retention and access management\n   - Obsolete document control\n\n4. **Corrective and Preventive Actions (21 CFR 820.100)**\n   - **CAPA System Implementation**: Follow references\u002Ffda-capa-requirements.md\n   - Investigation and root cause analysis procedures\n   - Corrective action implementation and verification\n   - Preventive action identification and implementation\n\n### 3. FDA Submission Preparation and Management\nLead comprehensive FDA submission preparation ensuring regulatory compliance and approval success.\n\n**510(k) Submission Process:**\n1. **Pre-submission Activities**\n   - Predicate device analysis and substantial equivalence strategy\n   - Q-Sub meeting preparation and FDA consultation\n   - Testing strategy development and validation\n   - **Decision Point**: Determine submission readiness and pathway confirmation\n\n2. **510(k) Preparation**\n   - **Device Description**: Comprehensive device characterization\n   - **Indications for Use**: Clinical indication and patient population\n   - **Substantial Equivalence Comparison**: Predicate device analysis\n   - **Performance Testing**: Bench testing, biocompatibility, software validation\n   - **Labeling**: Instructions for use and contraindications\n\n3. **FDA Review Management**\n   - FDA communication and additional information responses\n   - Review timeline monitoring and management\n   - FDA questions and clarification coordination\n   - Clearance letter processing and market launch preparation\n\n**PMA Submission Process:**\n1. **Clinical Investigation Requirements**\n   - IDE (Investigational Device Exemption) strategy and submission\n   - Clinical study protocol development and validation\n   - Good Clinical Practice (GCP) compliance oversight\n   - Clinical data analysis and statistical evaluation\n\n2. **PMA Application Preparation**\n   - Manufacturing information and quality system documentation\n   - Clinical and nonclinical safety and effectiveness data\n   - Risk analysis and benefit-risk assessment\n   - Labeling and post-market study commitments\n\n### 4. HIPAA Compliance and Healthcare Data Protection\nEnsure comprehensive HIPAA compliance for medical devices handling protected health information (PHI).\n\n**HIPAA Compliance Framework:**\n```\nHIPAA COMPLIANCE REQUIREMENTS\n├── Administrative Safeguards\n│   ├── Security officer designation\n│   ├── Workforce training and access management\n│   ├── Information access management\n│   └── Security awareness and training\n├── Physical Safeguards\n│   ├── Facility access controls\n│   ├── Workstation use restrictions\n│   ├── Device and media controls\n│   └── Equipment disposal procedures\n├── Technical Safeguards\n│   ├── Access control systems\n│   ├── Audit controls and monitoring\n│   ├── Integrity controls\n│   ├── Person or entity authentication\n│   └── Transmission security\n└── Business Associate Requirements\n    ├── Business associate agreements\n    ├── Subcontractor management\n    ├── Breach notification procedures\n    └── Risk assessment documentation\n```\n\n**HIPAA Risk Assessment Process:**\n1. **PHI Data Flow Analysis**\n   - PHI collection, storage, and transmission mapping\n   - Data access point identification and control\n   - Third-party data sharing evaluation\n   - Data retention and disposal procedures\n\n2. **Technical Safeguard Implementation**\n   - **For Connected Devices**: Follow references\u002Fdevice-cybersecurity-guidance.md\n   - **For Software Systems**: Follow references\u002Fsoftware-hipaa-compliance.md\n   - **For Cloud Services**: Follow references\u002Fcloud-hipaa-requirements.md\n   - Encryption and access control verification\n\n## Advanced FDA Regulatory Applications\n\n### Software as Medical Device (SaMD) Regulation\nNavigate complex FDA requirements for software-based medical devices ensuring compliance and efficient approval.\n\n**SaMD Regulatory Strategy:**\n- **Software Classification**: SaMD risk categorization per FDA guidance\n- **Software Documentation**: Software lifecycle documentation per FDA requirements\n- **Cybersecurity Requirements**: FDA cybersecurity guidance implementation\n- **Change Control**: Software modification and FDA notification requirements\n\n### Combination Product Regulation\nManage FDA combination product requirements ensuring proper classification and regulatory pathway selection.\n\n**Combination Product Framework:**\n- **OPDP Assignment**: Office of Product Development and Policy consultation\n- **Lead Center Determination**: CDER, CDRH, or CBER assignment\n- **Intercenter Agreement**: Cross-center coordination and communication\n- **Combination Product Guidance**: Product-specific regulatory guidance\n\n### FDA Cybersecurity Compliance\nImplement comprehensive cybersecurity measures meeting FDA requirements and guidance.\n\n**FDA Cybersecurity Requirements:**\n1. **Premarket Cybersecurity Requirements**\n   - Cybersecurity risk assessment and management\n   - Software bill of materials (SBOM) documentation\n   - Cybersecurity controls implementation and verification\n   - Vulnerability disclosure and management procedures\n\n2. **Post-market Cybersecurity Obligations**\n   - Cybersecurity monitoring and threat intelligence\n   - Security update and patch management\n   - Incident response and reporting procedures\n   - Coordinated vulnerability disclosure programs\n\n## FDA Inspection Readiness\n\n### FDA Inspection Preparation\nEnsure comprehensive readiness for FDA inspections including QSR compliance verification and documentation review.\n\n**Inspection Readiness Protocol:**\n- **Quality System Assessment**: QSR compliance verification and gap analysis\n- **Documentation Review**: Record completeness and regulatory compliance\n- **Personnel Training**: Inspection response and communication training\n- **Mock Inspection**: Internal inspection simulation and improvement\n\n### FDA Warning Letter Response\nManage FDA warning letter responses ensuring comprehensive corrective action and regulatory compliance restoration.\n\n**Warning Letter Response Strategy:**\n1. **Root Cause Analysis**: Systematic investigation and problem identification\n2. **Corrective Action Plan**: Comprehensive CAPA implementation\n3. **FDA Communication**: Professional response and timeline management\n4. **Verification Activities**: Effectiveness verification and compliance demonstration\n\n## Regulatory Intelligence and Strategy\n\n### FDA Guidance Monitoring\nMaintain current awareness of FDA guidance development and regulatory policy changes.\n\n**FDA Intelligence System:**\n- **Guidance Document Monitoring**: New and revised guidance tracking\n- **FDA Policy Changes**: Regulatory policy evolution and impact assessment\n- **Industry Communication**: FDA workshops, conferences, and stakeholder meetings\n- **Warning Letter Analysis**: Industry trends and enforcement patterns\n\n### Market Access Strategy\nDevelop comprehensive market access strategies optimizing FDA regulatory pathways and commercial objectives.\n\n**Market Access Planning:**\n- **Regulatory Strategy Development**: Pathway optimization and risk mitigation\n- **Competitive Intelligence**: Regulatory landscape analysis and positioning\n- **Timeline Optimization**: Regulatory milestone planning and resource allocation\n- **Commercial Integration**: Regulatory strategy and business objective alignment\n\n## Resources\n\n### scripts\u002F\n- `fda-submission-tracker.py`: FDA submission status monitoring and timeline management\n- `qsr-compliance-checker.py`: QSR compliance assessment and gap analysis tool\n- `hipaa-risk-assessment.py`: HIPAA compliance evaluation and documentation\n- `fda-guidance-monitor.py`: FDA guidance and policy change monitoring\n\n### references\u002F\n- `fda-submission-guide.md`: Comprehensive FDA submission preparation framework\n- `qsr-compliance-requirements.md`: 21 CFR 820 compliance implementation guide\n- `hipaa-compliance-framework.md`: Complete HIPAA compliance requirements\n- `device-cybersecurity-guidance.md`: FDA cybersecurity requirements and implementation\n- `fda-capa-requirements.md`: FDA CAPA system requirements and best practices\n\n### assets\u002F\n- `fda-templates\u002F`: FDA submission templates, forms, and checklists\n- `qsr-documentation\u002F`: QSR compliance documentation templates\n- `hipaa-tools\u002F`: HIPAA compliance assessment and documentation tools\n- `inspection-materials\u002F`: FDA inspection preparation and response materials\n","# Senior FDA Consultant and Specialist\n\nExpert-level FDA regulatory consulting with comprehensive knowledge of medical device regulations, Quality System Regulation (QSR), HIPAA compliance, cybersecurity requirements, and FDA submission pathways.\n\n## Core FDA Regulatory Competencies\n\n### 1. FDA Pathway Analysis and Selection\nProvide expert guidance on optimal FDA regulatory pathways ensuring efficient market access and regulatory compliance.\n\n**FDA Pathway Decision Framework:**\n```\nFDA REGULATORY PATHWAY SELECTION\n├── Device Classification Determination\n│   ├── Predicate device identification\n│   ├── Classification database research\n│   ├── Classification panel consultation\n│   └── De Novo pathway evaluation\n├── Submission Pathway Selection\n│   ├── 510(k) Clearance Assessment\n│   │   ├── Traditional 510(k)\n│   │   ├── Special 510(k)\n│   │   └── Abbreviated 510(k)\n│   ├── PMA (Premarket Approval) Evaluation\n│   │   ├── Original PMA\n│   │   ├── Panel-track supplement\n│   │   └── Real-time supplement\n│   └── De Novo Classification Request\n│       ├── Novel device evaluation\n│       ├── Risk classification\n│       └── Special controls development\n└── Pre-submission Strategy\n    ├── Q-Sub meeting planning\n    ├── FDA feedback integration\n    ├── Submission timeline optimization\n    └── Risk mitigation planning\n```\n\n### 2. Quality System Regulation (QSR) 21 CFR 820 Compliance\nEnsure comprehensive compliance with FDA Quality System Regulation throughout medical device lifecycle.\n\n**QSR Compliance Framework:**\n1. **Design Controls (21 CFR 820.30)**\n   - Design planning and procedures\n   - Design input requirements and documentation\n   - Design output specifications and verification\n   - Design review, verification, and validation\n   - Design transfer and change control\n\n2. **Management Responsibility (21 CFR 820.20)**\n   - Quality policy establishment and communication\n   - Organizational structure and responsibility\n   - Management representative designation\n   - Management review process implementation\n\n3. **Document Controls (21 CFR 820.40)**\n   - Document approval and distribution procedures\n   - Document change control processes\n   - Document retention and access management\n   - Obsolete document control\n\n4. **Corrective and Preventive Actions (21 CFR 820.100)**\n   - **CAPA System Implementation**: Follow references\u002Ffda-capa-requirements.md\n   - Investigation and root cause analysis procedures\n   - Corrective action implementation and verification\n   - Preventive action identification and implementation\n\n### 3. FDA Submission Preparation and Management\nLead comprehensive FDA submission preparation ensuring regulatory compliance and approval success.\n\n**510(k) Submission Process:**\n1. **Pre-submission Activities**\n   - Predicate device analysis and substantial equivalence strategy\n   - Q-Sub meeting preparation and FDA consultation\n   - Testing strategy development and validation\n   - **Decision Point**: Determine submission readiness and pathway confirmation\n\n2. **510(k) Preparation**\n   - **Device Description**: Comprehensive device characterization\n   - **Indications for Use**: Clinical indication and patient population\n   - **Substantial Equivalence Comparison**: Predicate device analysis\n   - **Performance Testing**: Bench testing, biocompatibility, software validation\n   - **Labeling**: Instructions for use and contraindications\n\n3. **FDA Review Management**\n   - FDA communication and additional information responses\n   - Review timeline monitoring and management\n   - FDA questions and clarification coordination\n   - Clearance letter processing and market launch preparation\n\n**PMA Submission Process:**\n1. **Clinical Investigation Requirements**\n   - IDE (Investigational Device Exemption) strategy and submission\n   - Clinical study protocol development and validation\n   - Good Clinical Practice (GCP) compliance oversight\n   - Clinical data analysis and statistical evaluation\n\n2. **PMA Application Preparation**\n   - Manufacturing information and quality system documentation\n   - Clinical and nonclinical safety and effectiveness data\n   - Risk analysis and benefit-risk assessment\n   - Labeling and post-market study commitments\n\n### 4. HIPAA Compliance and Healthcare Data Protection\nEnsure comprehensive HIPAA compliance for medical devices handling protected health information (PHI).\n\n**HIPAA Compliance Framework:**\n```\nHIPAA COMPLIANCE REQUIREMENTS\n├── Administrative Safeguards\n│   ├── Security officer designation\n│   ├── Workforce training and access management\n│   ├── Information access management\n│   └── Security awareness and training\n├── Physical Safeguards\n│   ├── Facility access controls\n│   ├── Workstation use restrictions\n│   ├── Device and media controls\n│   └── Equipment disposal procedures\n├── Technical Safeguards\n│   ├── Access control systems\n│   ├── Audit controls and monitoring\n│   ├── Integrity controls\n│   ├── Person or entity authentication\n│   └── Transmission security\n└── Business Associate Requirements\n    ├── Business associate agreements\n    ├── Subcontractor management\n    ├── Breach notification procedures\n    └── Risk assessment documentation\n```\n\n**HIPAA Risk Assessment Process:**\n1. **PHI Data Flow Analysis**\n   - PHI collection, storage, and transmission mapping\n   - Data access point identification and control\n   - Third-party data sharing evaluation\n   - Data retention and disposal procedures\n\n2. **Technical Safeguard Implementation**\n   - **For Connected Devices**: Follow references\u002Fdevice-cybersecurity-guidance.md\n   - **For Software Systems**: Follow references\u002Fsoftware-hipaa-compliance.md\n   - **For Cloud Services**: Follow references\u002Fcloud-hipaa-requirements.md\n   - Encryption and access control verification\n\n## Advanced FDA Regulatory Applications\n\n### Software as Medical Device (SaMD) Regulation\nNavigate complex FDA requirements for software-based medical devices ensuring compliance and efficient approval.\n\n**SaMD Regulatory Strategy:**\n- **Software Classification**: SaMD risk categorization per FDA guidance\n- **Software Documentation**: Software lifecycle documentation per FDA requirements\n- **Cybersecurity Requirements**: FDA cybersecurity guidance implementation\n- **Change Control**: Software modification and FDA notification requirements\n\n### Combination Product Regulation\nManage FDA combination product requirements ensuring proper classification and regulatory pathway selection.\n\n**Combination Product Framework:**\n- **OPDP Assignment**: Office of Product Development and Policy consultation\n- **Lead Center Determination**: CDER, CDRH, or CBER assignment\n- **Intercenter Agreement**: Cross-center coordination and communication\n- **Combination Product Guidance**: Product-specific regulatory guidance\n\n### FDA Cybersecurity Compliance\nImplement comprehensive cybersecurity measures meeting FDA requirements and guidance.\n\n**FDA Cybersecurity Requirements:**\n1. **Premarket Cybersecurity Requirements**\n   - Cybersecurity risk assessment and management\n   - Software bill of materials (SBOM) documentation\n   - Cybersecurity controls implementation and verification\n   - Vulnerability disclosure and management procedures\n\n2. **Post-market Cybersecurity Obligations**\n   - Cybersecurity monitoring and threat intelligence\n   - Security update and patch management\n   - Incident response and reporting procedures\n   - Coordinated vulnerability disclosure programs\n\n## FDA Inspection Readiness\n\n### FDA Inspection Preparation\nEnsure comprehensive readiness for FDA inspections including QSR compliance verification and documentation review.\n\n**Inspection Readiness Protocol:**\n- **Quality System Assessment**: QSR compliance verification and gap analysis\n- **Documentation Review**: Record completeness and regulatory compliance\n- **Personnel Training**: Inspection response and communication training\n- **Mock Inspection**: Internal inspection simulation and improvement\n\n### FDA Warning Letter Response\nManage FDA warning letter responses ensuring comprehensive corrective action and regulatory compliance restoration.\n\n**Warning Letter Response Strategy:**\n1. **Root Cause Analysis**: Systematic investigation and problem identification\n2. **Corrective Action Plan**: Comprehensive CAPA implementation\n3. **FDA Communication**: Professional response and timeline management\n4. **Verification Activities**: Effectiveness verification and compliance demonstration\n\n## Regulatory Intelligence and Strategy\n\n### FDA Guidance Monitoring\nMaintain current awareness of FDA guidance development and regulatory policy changes.\n\n**FDA Intelligence System:**\n- **Guidance Document Monitoring**: New and revised guidance tracking\n- **FDA Policy Changes**: Regulatory policy evolution and impact assessment\n- **Industry Communication**: FDA workshops, conferences, and stakeholder meetings\n- **Warning Letter Analysis**: Industry trends and enforcement patterns\n\n### Market Access Strategy\nDevelop comprehensive market access strategies optimizing FDA regulatory pathways and commercial objectives.\n\n**Market Access Planning:**\n- **Regulatory Strategy Development**: Pathway optimization and risk mitigation\n- **Competitive Intelligence**: Regulatory landscape analysis and positioning\n- **Timeline Optimization**: Regulatory milestone planning and resource allocation\n- **Commercial Integration**: Regulatory strategy and business objective alignment\n\n## Resources\n\n### scripts\u002F\n- `fda-submission-tracker.py`: FDA submission status monitoring and timeline management\n- `qsr-compliance-checker.py`: QSR compliance assessment and gap analysis tool\n- `hipaa-risk-assessment.py`: HIPAA compliance evaluation and documentation\n- `fda-guidance-monitor.py`: FDA guidance and policy change monitoring\n\n### references\u002F\n- `fda-submission-guide.md`: Comprehensive FDA submission preparation framework\n- `qsr-compliance-requirements.md`: 21 CFR 820 compliance implementation guide\n- `hipaa-compliance-framework.md`: Complete HIPAA compliance requirements\n- `device-cybersecurity-guidance.md`: FDA cybersecurity requirements and implementation\n- `fda-capa-requirements.md`: FDA CAPA system requirements and best practices\n\n### assets\u002F\n- `fda-templates\u002F`: FDA submission templates, forms, and checklists\n- `qsr-documentation\u002F`: QSR compliance documentation templates\n- `hipaa-tools\u002F`: HIPAA compliance assessment and documentation tools\n- `inspection-materials\u002F`: FDA inspection preparation and response materials\n",{"name":5,"description":7},"main","2b749c82b5d11fac39d9a6e021ce3f5b8a541bd1","cli-tool\u002Fcomponents\u002Fskills\u002Fenterprise-communication\u002Ffda-consultant-specialist",3931,"https:\u002F\u002Fgithub.com\u002Fdavila7\u002Fclaude-code-templates","https:\u002F\u002Faitmpl.com","https:\u002F\u002Fgithub.com\u002Fdavila7","https:\u002F\u002Fdanielavila.me","Building AI dev tools with LLMs","2026-11-14 06:14:46",{"source":8,"skillName":5,"commands":60,"prompt":70,"zipAvailable":71},[61,64,67],{"tool":62,"command":63},"npx","npx skills add 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fda-consultant-specialist","安装技能，技能地址：https:\u002F\u002Fgithub.com\u002Fdavila7\u002Fclaude-code-templates\u002Fblob\u002Fmain\u002Fcli-tool\u002Fcomponents\u002Fskills\u002Fenterprise-communication\u002Ffda-consultant-specialist\u002FSKILL.md",true,[73,79,85],{"path":74,"resourceType":75,"resourceTypeDesc":76,"sizeBytes":77,"sourceHtmlUrl":78},"assets\u002Fexample_asset.txt","ASSET","资产文件",865,"https:\u002F\u002Fgithub.com\u002Fdavila7\u002Fclaude-code-templates\u002Fblob\u002Fmain\u002Fcli-tool\u002Fcomponents\u002Fskills\u002Fenterprise-communication\u002Ffda-consultant-specialist\u002Fassets\u002Fexample_asset.txt",{"path":80,"resourceType":81,"resourceTypeDesc":82,"sizeBytes":83,"sourceHtmlUrl":84},"references\u002Fapi_reference.md","REFERENCE","参考文档",976,"https:\u002F\u002Fgithub.com\u002Fdavila7\u002Fclaude-code-templates\u002Fblob\u002Fmain\u002Fcli-tool\u002Fcomponents\u002Fskills\u002Fenterprise-communication\u002Ffda-consultant-specialist\u002Freferences\u002Fapi_reference.md",{"path":86,"resourceType":87,"resourceTypeDesc":88,"sizeBytes":89,"sourceHtmlUrl":90},"scripts\u002Fexample.py","SCRIPT","脚本",609,"https:\u002F\u002Fgithub.com\u002Fdavila7\u002Fclaude-code-templates\u002Fblob\u002Fmain\u002Fcli-tool\u002Fcomponents\u002Fskills\u002Fenterprise-communication\u002Ffda-consultant-specialist\u002Fscripts\u002Fexample.py",[92,122,149,180,215,239],{"skillNo":93,"name":94,"nameZh":6,"description":95,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":96,"categories":97,"keywords":103,"publishedAt":44},"01M70NHBTQ8BV0A2SCAZXEPHCX","wealthville-pool-scoring","Score DeFi liquidity pools before providing liquidity. Returns a 0-100 pool score and an Enter\u002FHold\u002FExit\u002FReduce\u002FAvoid verdict with calibrated confidence for ~68,800 Solana pools and 575 EVM pools, plus a public miss-inclusive track record. Use when asked whether a pool is worth LPing into, which pools look best right now, or how accurate the scores have actually been.","https:\u002F\u002Fgithub.com\u002Fdavila7\u002Fclaude-code-templates\u002Fblob\u002Fmain\u002Fcli-tool\u002Fcomponents\u002Fskills\u002Fweb-data\u002Fwealthville-pool-scoring\u002FSKILL.md",[98],{"categoryNo":99,"categoryName":100,"taxonomyType":101,"taxonomyTypeDesc":102},"01JBSEEDCAT000000000000023","Skill与智能体开发","SCENARIO","使用场景",[104,105,106,107,108,32,109,110,37,111,112,113,114,115,116,117,118,119,120,121],"scoring","pool","wealthville pool scoring","liquidity","which","exit","now","when","reduce","with","record","track","verdict","evm","solana","how","public","look",{"skillNo":123,"name":124,"nameZh":6,"description":125,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":126,"categories":127,"keywords":129,"publishedAt":44},"01M70MB6VR8ERJ4EM8D5KHBMEV","technical-debt-auditor","Scans a codebase and produces a quantified technical debt report with a prioritized remediation plan. Analyzes dead code, TODO\u002FFIXME\u002FHACK markers, dependency staleness, complexity hotspots, code duplication signals, test coverage gaps, unused exports, and outdated patterns. Use this skill when the user asks to audit their codebase for tech debt, wants a health check of their code quality, says things like \"where should I focus refactoring\", \"find code smells\", \"audit my codebase\", \"what technical debt do we have\", \"prioritize cleanup work\", or asks about code quality metrics. Also trigger when the user mentions \"code rot\", \"legacy cleanup\", \"refactoring priorities\", or wants to understand the overall health of a project before a major effort. Trigger even if the user doesn't say \"technical debt\" explicitly — any request to systematically assess code quality and identify improvement priorities belongs here.","https:\u002F\u002Fgithub.com\u002Fdavila7\u002Fclaude-code-templates\u002Fblob\u002Fmain\u002Fcli-tool\u002Fcomponents\u002Fskills\u002Fdevelopment\u002Ftechnical-debt-auditor\u002FSKILL.md",[128],{"categoryNo":99,"categoryName":100,"taxonomyType":101,"taxonomyTypeDesc":102},[130,131,132,133,134,135,136,137,138,139,140,111,141,142,143,144,145,146,147,148],"technical debt","debt","technical","technical debt auditor","auditor","coverage","complexity","markers","project","cleanup","unused","code","todo","work","plan","focus","signals","audit","dependency",{"skillNo":150,"name":151,"nameZh":6,"description":152,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":153,"categories":154,"keywords":162,"publishedAt":44},"01M70KPYH9QNHCNME5GJQGE22K","readonly-sql-guard","Make an agent's database access provably read-only. Use when an agent runs caller-supplied SQL against a production\u002FERP\u002Fanalytics database (a \"query\" MCP tool, text-to-SQL, an admin console), or when reviewing DB-access code for write\u002FDDL\u002Fside-effect\u002Ftransaction-escape risks. Checks what a statement CALLS, not just its shape.","https:\u002F\u002Fgithub.com\u002Fdavila7\u002Fclaude-code-templates\u002Fblob\u002Fmain\u002Fcli-tool\u002Fcomponents\u002Fskills\u002Fdatabase\u002Freadonly-sql-guard\u002FSKILL.md",[155,158,159],{"categoryNo":156,"categoryName":157,"taxonomyType":101,"taxonomyTypeDesc":102},"01JBSEEDCAT000000000000010","后端与接口",{"categoryNo":99,"categoryName":100,"taxonomyType":101,"taxonomyTypeDesc":102},{"categoryNo":160,"categoryName":161,"taxonomyType":21,"taxonomyTypeDesc":22},"01JBSEEDCAT000000000000033","数据分析师",[163,164,165,166,167,168,169,32,170,171,172,173,174,175,176,37,177,178,111,179],"readonly","guard","sql guard","sql","readonly sql guard","erp","effect","read-only","db","just","tool","calls","only","MCP","access","database","query",{"skillNo":181,"name":182,"nameZh":6,"description":183,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":184,"licenseFileUrl":185,"sourceHtmlUrl":186,"categories":187,"keywords":191,"publishedAt":44},"01M6AFY6F7CC2BBZP1QD6VTNVC","web-artifacts-builder","Suite of tools for creating elaborate, multi-component claude.ai HTML artifacts using modern frontend web technologies (React, Tailwind CSS, shadcn\u002Fui). Use for complex artifacts requiring state management, routing, or shadcn\u002Fui components - not for simple single-file HTML\u002FJSX artifacts.","Apache-2.0","https:\u002F\u002Fgithub.com\u002Fdavila7\u002Fclaude-code-templates\u002Fblob\u002Fmain\u002Fcli-tool\u002Fcomponents\u002Fskills\u002Futilities\u002Fweb-artifacts-builder\u002FLICENSE.txt","https:\u002F\u002Fgithub.com\u002Fdavila7\u002Fclaude-code-templates\u002Fblob\u002Fmain\u002Fcli-tool\u002Fcomponents\u002Fskills\u002Futilities\u002Fweb-artifacts-builder\u002FSKILL.md",[188],{"categoryNo":189,"categoryName":190,"taxonomyType":101,"taxonomyTypeDesc":102},"01JBSEEDCAT000000000000009","前端开发",[192,193,194,195,196,197,198,199,200,201,202,203,204,205,206,207,208,209,210,211,212,213,32,214],"artifacts builder","web","web artifacts builder","artifacts","builder","state","routing","state management","component","css","frontend","ui","Tools","file","components","shadcn","react","Tailwind","suite","jsx","html","single-file","ui components",{"skillNo":216,"name":217,"nameZh":6,"description":218,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":184,"licenseFileUrl":219,"sourceHtmlUrl":220,"categories":221,"keywords":226,"publishedAt":44},"01M6AFWF33SFV9Z3SF4PEEE4BF","webapp-testing","Toolkit for interacting with and testing local web applications using Playwright. Supports verifying frontend functionality, debugging UI behavior, capturing browser screenshots, and viewing browser logs.","https:\u002F\u002Fgithub.com\u002Fdavila7\u002Fclaude-code-templates\u002Fblob\u002Fmain\u002Fcli-tool\u002Fcomponents\u002Fskills\u002Fsecurity\u002Fwebapp-testing\u002FLICENSE.txt","https:\u002F\u002Fgithub.com\u002Fdavila7\u002Fclaude-code-templates\u002Fblob\u002Fmain\u002Fcli-tool\u002Fcomponents\u002Fskills\u002Fsecurity\u002Fwebapp-testing\u002FSKILL.md",[222,225],{"categoryNo":223,"categoryName":224,"taxonomyType":101,"taxonomyTypeDesc":102},"01JBSEEDCAT000000000000008","测试与质量",{"categoryNo":189,"categoryName":190,"taxonomyType":101,"taxonomyTypeDesc":102},[227,228,229,230,231,193,232,202,203,233,234,235,236,32,237,113,238],"webapp testing","testing","webapp","browser","playwright","applications","debugging","toolkit","logs","screenshots","local","behavior",{"skillNo":240,"name":241,"nameZh":6,"description":242,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":184,"licenseFileUrl":243,"sourceHtmlUrl":244,"categories":245,"keywords":253,"publishedAt":44},"01M6AF67Q67JJJ5V51JR2P52KA","discernment-nudge","After you give a substantive answer or draft that the user may act on — advice or recommendations, drafted artifacts such as goals, plans, pitches, proposals, or emails, estimates or projections, analysis or interpretation of data, factual claims they may rely on, or a multi-step argument — invoke this skill BEFORE finalizing your reply and then, if it applies, append 2-3 short follow-up questions, each tied to something specific in what you just produced, that help the user check key facts, probe the reasoning or assumptions, and notice missing context. Do this at most once per conversation. Skip it when the user asked a trivial how-to or simple lookup, wants a purely educational explanation, asked you only to format, convert, or assemble a file from content they provided, is writing code they will run, is doing creative writing or casual chat, or already asked you to double-check, cite, or review — the skill file explains these boundaries and the exact output format.","https:\u002F\u002Fgithub.com\u002Fdavila7\u002Fclaude-code-templates\u002Fblob\u002Fmain\u002Fcli-tool\u002Fcomponents\u002Fskills\u002Fproductivity\u002Fdiscernment-nudge\u002FLICENSE.txt","https:\u002F\u002Fgithub.com\u002Fdavila7\u002Fclaude-code-templates\u002Fblob\u002Fmain\u002Fcli-tool\u002Fcomponents\u002Fskills\u002Fproductivity\u002Fdiscernment-nudge\u002FSKILL.md",[246,249,250],{"categoryNo":247,"categoryName":248,"taxonomyType":101,"taxonomyTypeDesc":102},"01JBSEEDCAT000000000000018","写作与文案",{"categoryNo":99,"categoryName":100,"taxonomyType":101,"taxonomyTypeDesc":102},{"categoryNo":251,"categoryName":252,"taxonomyType":21,"taxonomyTypeDesc":22},"01JBSEEDCAT000000000000036","内容创作者",[254,255,256,257,258,259,260,261,195,262,205,141,263,264,265,266,267,175,268,111,269,270,271,272,273,119,274],"discernment nudge","nudge","interpretation","help","run","reasoning","data","writing","lookup","content","review","conversation","short","up","invoke","you","analysis","claims","argument","assemble","recommendations"]