# Send Fda Consultant Specialist to your agent Hand the extracted package to your coding agent with a concrete install brief instead of figuring it out manually. ## Fast path - Download the package from Yavira. - Extract it into a folder your agent can access. - Paste one of the prompts below and point your agent at the extracted folder. ## Suggested prompts ### New install ```text I downloaded a skill package from Yavira. Read SKILL.md from the extracted folder and install it by following the included instructions. Tell me what you changed and call out any manual steps you could not complete. ``` ### Upgrade existing ```text I downloaded an updated skill package from Yavira. Read SKILL.md from the extracted folder, compare it with my current installation, and upgrade it while preserving any custom configuration unless the package docs explicitly say otherwise. Summarize what changed and any follow-up checks I should run. ``` ## Machine-readable fields ```json { "schemaVersion": "1.0", "item": { "slug": "fda-consultant-specialist", "name": "Fda Consultant Specialist", "source": "tencent", "type": "skill", "category": "AI 智能", "sourceUrl": "https://clawhub.ai/alirezarezvani/fda-consultant-specialist", "canonicalUrl": "https://clawhub.ai/alirezarezvani/fda-consultant-specialist", "targetPlatform": "OpenClaw" }, "install": { "downloadUrl": "/downloads/fda-consultant-specialist", "sourceDownloadUrl": "https://wry-manatee-359.convex.site/api/v1/download?slug=fda-consultant-specialist", "sourcePlatform": "tencent", "targetPlatform": "OpenClaw", "packageFormat": "ZIP package", "primaryDoc": "SKILL.md", "includedAssets": [ "SKILL.md", "references/device_cybersecurity_guidance.md", "references/fda_capa_requirements.md", "references/fda_submission_guide.md", "references/hipaa_compliance_framework.md", "references/qsr_compliance_requirements.md" ], "downloadMode": "redirect", "sourceHealth": { "source": "tencent", "status": "healthy", "reason": "direct_download_ok", "recommendedAction": "download", "checkedAt": "2026-04-30T16:55:25.780Z", "expiresAt": "2026-05-07T16:55:25.780Z", "httpStatus": 200, "finalUrl": "https://wry-manatee-359.convex.site/api/v1/download?slug=network", "contentType": "application/zip", "probeMethod": "head", "details": { "probeUrl": "https://wry-manatee-359.convex.site/api/v1/download?slug=network", "contentDisposition": "attachment; filename=\"network-1.0.0.zip\"", "redirectLocation": null, "bodySnippet": null }, "scope": "source", "summary": "Source download looks usable.", "detail": "Yavira can redirect you to the upstream package for this source.", "primaryActionLabel": "Download for OpenClaw", "primaryActionHref": "/downloads/fda-consultant-specialist" }, "validation": { "installChecklist": [ "Use the Yavira download entry.", "Review SKILL.md after the package is downloaded.", "Confirm the extracted package contains the expected setup assets." ], "postInstallChecks": [ "Confirm the extracted package includes the expected docs or setup files.", "Validate the skill or prompts are available in your target agent workspace.", "Capture any manual follow-up steps the agent could not complete." ] } }, "links": { "detailUrl": "https://openagent3.xyz/skills/fda-consultant-specialist", "downloadUrl": "https://openagent3.xyz/downloads/fda-consultant-specialist", "agentUrl": "https://openagent3.xyz/skills/fda-consultant-specialist/agent", "manifestUrl": "https://openagent3.xyz/skills/fda-consultant-specialist/agent.json", "briefUrl": "https://openagent3.xyz/skills/fda-consultant-specialist/agent.md" } } ``` ## Documentation ### FDA Consultant Specialist FDA regulatory consulting for medical device manufacturers covering submission pathways, Quality System Regulation (QSR), HIPAA compliance, and device cybersecurity requirements. ### Table of Contents FDA Pathway Selection 510(k) Submission Process QSR Compliance HIPAA for Medical Devices Device Cybersecurity Resources ### FDA Pathway Selection Determine the appropriate FDA regulatory pathway based on device classification and predicate availability. ### Decision Framework Predicate device exists? ├── YES → Substantially equivalent? │ ├── YES → 510(k) Pathway │ │ ├── No design changes → Abbreviated 510(k) │ │ ├── Manufacturing only → Special 510(k) │ │ └── Design/performance → Traditional 510(k) │ └── NO → PMA or De Novo └── NO → Novel device? ├── Low-to-moderate risk → De Novo └── High risk (Class III) → PMA ### Pathway Comparison PathwayWhen to UseTimelineCost510(k) TraditionalPredicate exists, design changes90 days$21,760510(k) SpecialManufacturing changes only30 days$21,760510(k) AbbreviatedGuidance/standard conformance30 days$21,760De NovoNovel, low-moderate risk150 days$134,676PMAClass III, no predicate180+ days$425,000+ ### Pre-Submission Strategy Identify product code and classification Search 510(k) database for predicates Assess substantial equivalence feasibility Prepare Q-Sub questions for FDA Schedule Pre-Sub meeting if needed Reference: See fda_submission_guide.md for pathway decision matrices and submission requirements. ### Workflow Phase 1: Planning ├── Step 1: Identify predicate device(s) ├── Step 2: Compare intended use and technology ├── Step 3: Determine testing requirements └── Checkpoint: SE argument feasible? Phase 2: Preparation ├── Step 4: Complete performance testing ├── Step 5: Prepare device description ├── Step 6: Document SE comparison ├── Step 7: Finalize labeling └── Checkpoint: All required sections complete? Phase 3: Submission ├── Step 8: Assemble submission package ├── Step 9: Submit via eSTAR ├── Step 10: Track acknowledgment └── Checkpoint: Submission accepted? Phase 4: Review ├── Step 11: Monitor review status ├── Step 12: Respond to AI requests ├── Step 13: Receive decision └── Verification: SE letter received? ### Required Sections (21 CFR 807.87) SectionContentCover LetterSubmission type, device ID, contact infoForm 3514CDRH premarket review cover sheetDevice DescriptionPhysical description, principles of operationIndications for UseForm 3881, patient population, use environmentSE ComparisonSide-by-side comparison with predicatePerformance TestingBench, biocompatibility, electrical safetySoftware DocumentationLevel of concern, hazard analysis (IEC 62304)LabelingIFU, package labels, warnings510(k) SummaryPublic summary of submission ### Common RTA Issues IssuePreventionMissing user feeVerify payment before submissionIncomplete Form 3514Review all fields, ensure signatureNo predicate identifiedConfirm K-number in FDA databaseInadequate SE comparisonAddress all technological characteristics ### QSR Compliance Quality System Regulation (21 CFR Part 820) requirements for medical device manufacturers. ### Key Subsystems SectionTitleFocus820.20Management ResponsibilityQuality policy, org structure, management review820.30Design ControlsInput, output, review, verification, validation820.40Document ControlsApproval, distribution, change control820.50Purchasing ControlsSupplier qualification, purchasing data820.70Production ControlsProcess validation, environmental controls820.100CAPARoot cause analysis, corrective actions820.181Device Master RecordSpecifications, procedures, acceptance criteria ### Design Controls Workflow (820.30) Step 1: Design Input └── Capture user needs, intended use, regulatory requirements Verification: Inputs reviewed and approved? Step 2: Design Output └── Create specifications, drawings, software architecture Verification: Outputs traceable to inputs? Step 3: Design Review └── Conduct reviews at each phase milestone Verification: Review records with signatures? Step 4: Design Verification └── Perform testing against specifications Verification: All tests pass acceptance criteria? Step 5: Design Validation └── Confirm device meets user needs in actual use conditions Verification: Validation report approved? Step 6: Design Transfer └── Release to production with DMR complete Verification: Transfer checklist complete? ### CAPA Process (820.100) Identify: Document nonconformity or potential problem Investigate: Perform root cause analysis (5 Whys, Fishbone) Plan: Define corrective/preventive actions Implement: Execute actions, update documentation Verify: Confirm implementation complete Effectiveness: Monitor for recurrence (30-90 days) Close: Management approval and closure Reference: See qsr_compliance_requirements.md for detailed QSR implementation guidance. ### HIPAA for Medical Devices HIPAA requirements for devices that create, store, transmit, or access Protected Health Information (PHI). ### Applicability Device TypeHIPAA AppliesStandalone diagnostic (no data transmission)NoConnected device transmitting patient dataYesDevice with EHR integrationYesSaMD storing patient informationYesWellness app (no diagnosis)Only if stores PHI ### Required Safeguards Administrative (§164.308) ├── Security officer designation ├── Risk analysis and management ├── Workforce training ├── Incident response procedures └── Business associate agreements Physical (§164.310) ├── Facility access controls ├── Workstation security └── Device disposal procedures Technical (§164.312) ├── Access control (unique IDs, auto-logoff) ├── Audit controls (logging) ├── Integrity controls (checksums, hashes) ├── Authentication (MFA recommended) └── Transmission security (TLS 1.2+) ### Risk Assessment Steps Inventory all systems handling ePHI Document data flows (collection, storage, transmission) Identify threats and vulnerabilities Assess likelihood and impact Determine risk levels Implement controls Document residual risk Reference: See hipaa_compliance_framework.md for implementation checklists and BAA templates. ### Device Cybersecurity FDA cybersecurity requirements for connected medical devices. ### Premarket Requirements ElementDescriptionThreat ModelSTRIDE analysis, attack trees, trust boundariesSecurity ControlsAuthentication, encryption, access controlSBOMSoftware Bill of Materials (CycloneDX or SPDX)Security TestingPenetration testing, vulnerability scanningVulnerability PlanDisclosure process, patch management ### Device Tier Classification Tier 1 (Higher Risk): Connects to network/internet Cybersecurity incident could cause patient harm Tier 2 (Standard Risk): All other connected devices ### Postmarket Obligations Monitor NVD and ICS-CERT for vulnerabilities Assess applicability to device components Develop and test patches Communicate with customers Report to FDA per guidance ### Coordinated Vulnerability Disclosure Researcher Report ↓ Acknowledgment (48 hours) ↓ Initial Assessment (5 days) ↓ Fix Development ↓ Coordinated Public Disclosure Reference: See device_cybersecurity_guidance.md for SBOM format examples and threat modeling templates. ### scripts/ ScriptPurposefda_submission_tracker.pyTrack 510(k)/PMA/De Novo submission milestones and timelinesqsr_compliance_checker.pyAssess 21 CFR 820 compliance against project documentationhipaa_risk_assessment.pyEvaluate HIPAA safeguards in medical device software ### references/ FileContentfda_submission_guide.md510(k), De Novo, PMA submission requirements and checklistsqsr_compliance_requirements.md21 CFR 820 implementation guide with templateshipaa_compliance_framework.mdHIPAA Security Rule safeguards and BAA requirementsdevice_cybersecurity_guidance.mdFDA cybersecurity requirements, SBOM, threat modelingfda_capa_requirements.mdCAPA process, root cause analysis, effectiveness verification ### Usage Examples # Track FDA submission status python scripts/fda_submission_tracker.py /path/to/project --type 510k # Assess QSR compliance python scripts/qsr_compliance_checker.py /path/to/project --section 820.30 # Run HIPAA risk assessment python scripts/hipaa_risk_assessment.py /path/to/project --category technical ## Trust - Source: tencent - Verification: Indexed source record - Publisher: alirezarezvani - Version: 2.1.1 ## Source health - Status: healthy - Source download looks usable. - Yavira can redirect you to the upstream package for this source. - Health scope: source - Reason: direct_download_ok - Checked at: 2026-04-30T16:55:25.780Z - Expires at: 2026-05-07T16:55:25.780Z - Recommended action: Download for OpenClaw ## Links - [Detail page](https://openagent3.xyz/skills/fda-consultant-specialist) - [Send to Agent page](https://openagent3.xyz/skills/fda-consultant-specialist/agent) - [JSON manifest](https://openagent3.xyz/skills/fda-consultant-specialist/agent.json) - [Markdown brief](https://openagent3.xyz/skills/fda-consultant-specialist/agent.md) - [Download page](https://openagent3.xyz/downloads/fda-consultant-specialist)