FDA Medical Device SBOM Guidance for Premarket Cybersecurity Reviews

{
  "document": {
    "name": "Medical Device SBOM",
    "namespace": "https://company.com/medical-device-v1.0",
    "creator": "Device Manufacturer",
    "created": "2025-01-27T10:00:00Z",
    "supplier": "Company Inc",
    "license": "Proprietary"
  },
  "components": [
    {
      "name": "Patient Monitor Software",
      "version": "2.1.0",
      "purl": "pkg:medical/patient-monitor@2.1.0",
      "supplier": "Company Inc",
      "license": "Proprietary",
      "safety_classification": "Class II",
      "cybersecurity_controls": [
        "authentication",
        "encryption",
        "access_control"
      ],
      "vulnerability_assessment": {
        "last_updated": "2025-01-15",
        "known_vulnerabilities": 0,
        "risk_score": "low"
      }
    }
  ]
}

medical_device_info:
  device_classification: "Class II"
  predicate_device: "K123456"
  intended_use: "Continuous patient monitoring"
  safety_functions: 
    - "Heart rate monitoring"
    - "Blood pressure measurement"
    - "Alarm generation"

cybersecurity_controls:
  authentication:
    - type: "Multi-factor"
    - implementation: "LDAP integration"

  encryption:
    - data_at_rest: "AES-256"
    - data_in_transit: "TLS 1.3"

  access_control:
    - model: "Role-based"
    - audit_logging: "Enabled"

software_lifecycle:
  development_process: "IEC 62304"
  risk_management: "ISO 14971"
  quality_system: "ISO 13485"

# Section J: Software Documentation

## Software Bill of Materials (SBOM)
Attached SBOM (Attachment J-1) includes:
- Complete inventory of software components
- Version information for all components
- License identification and compliance analysis
- Cybersecurity risk assessment for each component
- Vulnerability management procedures

## COTS Software Analysis
Commercial software components assessed:
1. **Operating System**: Linux Embedded 5.4.0
   - Security patches: Current
   - Support lifecycle: 5 years remaining
   - Risk assessment: Low

2. **Database**: PostgreSQL 13.8
   - Known vulnerabilities: None (critical/high)
   - Patch management: Automated monthly
   - Risk assessment: Low

## Open Source Components
Total open source components: 47
High-risk components: 0
License compliance status: Compliant
Vulnerability monitoring: Automated daily scans

# Example enhanced SBOM evidence package for novel devices
sbom_requirements:
  completeness:
    - all_software_components: "Document"
    - firmware_components: "Document when applicable"
    - embedded_libraries: "Document"
    - network_protocols: "Document when applicable"

  security_analysis:
    - threat_modeling: "Per NIST framework"
    - penetration_testing: "Annual"
    - vulnerability_scanning: "Continuous"

  documentation:
    - architecture_diagrams: "Prepare for review"
    - data_flow_diagrams: "Prepare for review"
    - security_controls_matrix: "Prepare for review"
    - incident_response_plan: "Prepare for review"

#!/usr/bin/env python3
import json
from datetime import datetime

class MedicalDeviceSBOM:
    def __init__(self, device_info):
        self.device_info = device_info
        self.components = []
        self.cybersecurity_controls = {}

    def add_component(self, component):
        """Add component with medical device-specific validation"""
        # Validate fields commonly needed for FDA-facing cybersecurity review
        required_fields = [
            'name', 'version', 'supplier', 'license',
            'safety_classification', 'cybersecurity_controls'
        ]

        for field in required_fields:
            if field not in component:
                raise ValueError(f"Missing required field: {field}")

        # Assess component risk
        component['risk_assessment'] = self.assess_component_risk(component)

        # Check for known vulnerabilities
        component['vulnerability_status'] = self.check_vulnerabilities(component)

        self.components.append(component)

    def assess_component_risk(self, component):
        """Submission-supporting cybersecurity risk assessment"""
        risk_score = 0

        # Network connectivity increases risk
        if 'network' in component.get('capabilities', []):
            risk_score += 3

        # Data handling capabilities
        if 'patient_data' in component.get('data_types', []):
            risk_score += 4

        # Safety function involvement
        if component.get('safety_function'):
            risk_score += 2

        # License risk
        if component.get('license') in ['GPL', 'AGPL']:
            risk_score += 1

        if risk_score >= 7:
            return 'High'
        elif risk_score >= 4:
            return 'Medium'
        else:
            return 'Low'

    def generate_fda_submission(self):
        """Generate an SBOM package for FDA-facing review"""
        sbom = {
            "document": {
                "name": f"{self.device_info['name']} SBOM",
                "version": "1.0",
                "created": datetime.now().isoformat(),
                "namespace": f"https://{self.device_info['manufacturer']}.com/{self.device_info['name']}",
                "supplier": self.device_info['manufacturer']
            },
            "device_information": {
                "name": self.device_info['name'],
                "classification": self.device_info['classification'],
                "intended_use": self.device_info['intended_use'],
                "predicate_device": self.device_info.get('predicate_device'),
                "regulatory_pathway": self.device_info['pathway']
            },
            "components": self.components,
            "cybersecurity_summary": self.generate_cybersecurity_summary(),
            "vulnerability_management": {
                "process": "Continuous monitoring with monthly reviews",
                "tools": ["Grype", "Snyk", "WhiteSource"],
                "response_time": {
                    "critical": "24 hours",
                    "high": "72 hours",
                    "medium": "7 days"
                }
            }
        }

        return sbom

    def generate_cybersecurity_summary(self):
        """Cybersecurity controls summary for FDA"""
        controls = {
            "authentication": False,
            "authorization": False,
            "encryption": False,
            "audit_logging": False,
            "secure_communication": False,
            "automatic_updates": False
        }

        for component in self.components:
            for control in component.get('cybersecurity_controls', []):
                if control in controls:
                    controls[control] = True

        return {
            "implemented_controls": [k for k, v in controls.items() if v],
            "control_coverage": f"{sum(controls.values())}/{len(controls)} controls",
            "risk_mitigation": "Comprehensive cybersecurity controls implemented"
        }

# Usage example
device = MedicalDeviceSBOM({
    'name': 'SmartCare Patient Monitor',
    'manufacturer': 'MedTech Corp',
    'classification': 'Class II',
    'intended_use': 'Continuous patient vital signs monitoring',
    'pathway': '510(k)'
})

device.add_component({
    'name': 'Patient Monitor OS',
    'version': '2.1.0',
    'supplier': 'MedTech Corp',
    'license': 'Proprietary',
    'safety_classification': 'Class II',
    'safety_function': True,
    'capabilities': ['network', 'data_storage'],
    'data_types': ['patient_data', 'device_logs'],
    'cybersecurity_controls': ['authentication', 'encryption', 'audit_logging']
})

fda_sbom = device.generate_fda_submission()
print(json.dumps(fda_sbom, indent=2))

# ISO 13485 SBOM Procedures
procedures:
  document_control:
    procedure_id: "QP-SW-001"
    title: "Software Bill of Materials Management"
    version: "1.2"
    approval_date: "2025-01-15"

  sbom_generation:
    frequency: "Every software release"
    tools: ["Syft", "SPDX Tools"]
    validation: "Independent review required"

  risk_management:
    standard: "ISO 14971"
    software_risk_file: "Required for Class II/III"
    sbom_risk_analysis: "Quarterly review"

  change_control:
    sbom_updates: "Version controlled"
    impact_assessment: "Required for all changes"
    approval_workflow: "QA → Engineering → Regulatory"

## SBOM Audit Package
1. **Current SBOM** (SPDX or CycloneDX format)
2. **Component Risk Assessments** (Individual and cumulative)
3. **Vulnerability Management Records** (Last 24 months)
4. **License Compliance Documentation**
5. **Third-party Software Agreements**
6. **Cybersecurity Test Reports**
7. **Incident Response Records**
8. **Software Change History**

## Process Evidence
- SBOM generation procedures (SOPs)
- Validation and verification records
- Training records for SBOM management
- Supplier qualification documentation
- Configuration management procedures

fda_questions:
  completeness:
    q: "How do you ensure SBOM completeness?"
    response: "Automated generation with manual verification checklist"
    evidence: "SBOM validation reports and test records"

  accuracy:
    q: "How do you validate SBOM accuracy?"
    response: "Independent review and automated scanning verification"
    evidence: "Validation procedures and review records"

  currency:
    q: "How frequently are SBOMs updated?"
    response: "With every software release and monthly vulnerability reviews"
    evidence: "Change control records and update logs"

  risk_management:
    q: "How are software component risks assessed?"
    response: "ISO 14971 risk management process with SBOM integration"
    evidence: "Risk management files and assessment matrices"

# Medical device cybersecurity alignment
nist_csf_mapping:
  identify:
    asset_management:
      control: "ID.AM-2"
      implementation: "SBOM provides complete software inventory"
      evidence: "Current SBOM with component catalog"

    risk_assessment:
      control: "ID.RA-1"
      implementation: "SBOM-based vulnerability and license risk assessment"
      evidence: "Risk assessment matrices per component"

  protect:
    access_control:
      control: "PR.AC-3"
      implementation: "Component access controls documented in SBOM"
      evidence: "Access control matrix and user management procedures"

  detect:
    security_monitoring:
      control: "DE.CM-8"
      implementation: "Continuous vulnerability scanning of SBOM components"
      evidence: "Vulnerability scan reports and monitoring logs"

iec_62304_integration:
  software_planning:
    activity: "Software Development Planning"
    sbom_requirement: "SBOM generation plan"
    deliverable: "SBOM template and procedures"

  software_requirements:
    activity: "Software Requirements Analysis"
    sbom_requirement: "Component selection criteria"
    deliverable: "Approved components list"

  software_architecture:
    activity: "Software Architectural Design"
    sbom_requirement: "Architecture-SBOM traceability"
    deliverable: "Component architecture diagram"

  software_implementation:
    activity: "Software Implementation"
    sbom_requirement: "Build-time SBOM generation"
    deliverable: "Automated SBOM pipeline"

  software_testing:
    activity: "Software System Testing"
    sbom_requirement: "SBOM validation testing"
    deliverable: "SBOM test reports"

eu_mdr_requirements:
  article_10_4:
    requirement: "Software as Medical Device documentation"
    sbom_relevance: "SBOM provides required software transparency"

  article_117:
    requirement: "Post-market surveillance"
    sbom_relevance: "SBOM enables vulnerability tracking and incident response"

  annex_xiv:
    requirement: "Clinical evaluation and post-market clinical follow-up"
    sbom_relevance: "Software component safety analysis"

health_canada:
  guidance_doc: "Software as Medical Device (SaMD)"
  sbom_requirements:
    - "Complete software component inventory"
    - "Cybersecurity risk documentation"
    - "Third-party software risk assessment"
    - "Vulnerability management process"

supplier_requirements:
  sbom_provision:
    - "Suppliers must provide component SBOMs"
    - "SBOMs must include vulnerability status"
    - "License information must be complete"

  security_requirements:
    - "Secure development lifecycle (SDL)"
    - "Vulnerability disclosure process"
    - "Security testing evidence"

  ongoing_obligations:
    - "Monthly security updates"
    - "Immediate critical vulnerability notification"
    - "End-of-life migration planning"