---
title: "FOSSA for Medical Devices | SBOM Compliance & Security"
description: "Meet FDA SBOM requirements with FOSSA. Generate comprehensive SBOMs, track vulnerabilities, and streamline compliance for medical device software to secure FDA premarket approval."
canonical_url: "https://fossa.com/industries/medical-device/"
markdown_url: "https://fossa.com/industries/medical-device.md"
language: "en"
author: "FOSSA"
organization: "FOSSA"
---

# FOSSA for Medical Devices | SBOM Compliance & Security

> Meet FDA SBOM requirements with FOSSA. Generate comprehensive SBOMs, track vulnerabilities, and streamline compliance for medical device software to secure FDA premarket approval.

Medical Device

## 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.

1

Patient-Facing Software

Mobile apps and diagnostic interfaces with 150+ packages

2

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.

2023

FDA SBOM requirements took effect

400+

Average components in medical device software

80%

Reduction in compliance prep time with FOSSA

300%

Growth in medical device security incidents

### 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

FDA Compliance Efficiency

5x

FOSSA customers complete FDA submissions up to 5 times faster by automating SBOM generation and analysis

### 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

### Secure FDA Approval with Confidence

Join leading medical device manufacturers using FOSSA to meet FDA SBOM requirements, secure their software supply chain, and streamline regulatory approval.

## Source

Canonical page: https://fossa.com/industries/medical-device/