FDA-Ready SBOM Compliance for Medical Devices
Meet FDA premarket submission requirements with automated SBOM generation, vulnerability management, and complete software supply chain visibility for medical devices.
Patient-Facing Software
Mobile apps and diagnostic interfaces with 150+ packages
Device Control & Firmware
Critical embedded software with 100+ components
FDA Now Requires SBOMs for Medical Devices
Since October 2023, the FDA has had the authority to reject premarket submissions that lack comprehensive SBOMs and cybersecurity information. FOSSA helps medical device manufacturers meet these requirements quickly and effectively.
Complete FDA Premarket Submission Support
FOSSA provides all the tools medical device manufacturers need to meet FDA SBOM requirements and secure premarket approval for their devices.
SBOM Generation
Generate machine-readable SBOMs with all NTIA-required elements for FDA submissions, including component inventory, dependencies, and supplier information.
- CycloneDX and SPDX format support
- Comprehensive component tracking
- Automated SBOM generation in CI/CD
Vulnerability Management
Complete vulnerability assessment documentation for FDA submissions, with detailed context on each vulnerability and suggested remediation steps.
- Full inventory of known vulnerabilities
- CVE scoring and context
- Actionable remediation guidance
VEX Integration
Codify internal vulnerability assessments with NTIA-compliant VEX status and justifications for automated generation and communication of exploitability.
- NTIA-compliant VEX statuses
- Automated VEX generation
- Clear exploitability communication
Meet FDA and Regulatory Requirements
FOSSA helps medical device manufacturers meet FDA premarket submission requirements and other industry-specific regulations with comprehensive SBOM management.
FDA Premarket Requirements
SBOM requirements for medical devices
510(k) & PMA Submissions
Comprehensive cybersecurity documentation
Postmarket Monitoring
Ongoing vulnerability tracking and remediation
Complete FDA SBOM Requirements Coverage
FOSSA helps medical device manufacturers meet all FDA-required elements for SBOM submissions.
NTIA Minimum Elements
FOSSA generates SBOMs that include all NTIA-required minimum elements in a machine-readable format.
- Component name, supplier, and version
- Dependency relationships between components
- Component identifiers (CPE, PURL)
- SBOM author and timestamp data
Ongoing Support & Monitoring
FOSSA provides the continuous monitoring and vulnerability assessment required for FDA postmarket submissions.
- Component support status tracking
- End-of-life component identification
- Real-time vulnerability notifications
- Package risk and health assessment