Tencent SkillHub · AI

Fda Consultant Specialist

FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QSR (21 CFR 820) compliance, HIPAA assessments, and device cybersecurity. Use when user mentions FDA submission, 510(k), PMA, De Novo, QSR, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity.

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Target platform: OpenClaw
Install method: Manual import
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Prerequisites: OpenClaw
Primary doc: SKILL.md

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Package format: ZIP package
Source platform: Tencent SkillHub
What's included: 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

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Release facts

Source: Tencent SkillHub
Verification: Indexed source record
Version: 2.1.1

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Publisher: alirezarezvani
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Documentation

ClawHub primary doc Primary doc: SKILL.md 25 sections Open source page

FDA Consultant Specialist

FDA regulatory consulting for medical device manufacturers covering submission pathways, Quality System Regulation (QSR), HIPAA compliance, and device cybersecurity requirements.

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

Category context

Agent frameworks, memory systems, reasoning layers, and model-native orchestration.

Source: Tencent SkillHub

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Package contents

Included in package

6 Docs

SKILL.md Primary doc
references/device_cybersecurity_guidance.md Docs
references/fda_capa_requirements.md Docs
references/fda_submission_guide.md Docs
references/hipaa_compliance_framework.md Docs
references/qsr_compliance_requirements.md Docs