FDA premarket cybersecurity, simplified
The FDA's 2023 final guidance made SBOMs mandatory for premarket submissions. We turn months of documentation into a download.
The challenges we hear
Premarket submissions held for SBOM gaps
The FDA has begun holding submissions that lack adequate SBOMs. Resubmission costs months.
Post-market CVE response obligations
Once a device is shipping, you're responsible for tracking and disclosing newly discovered vulnerabilities — for the device's lifetime.
EU MDR + CRA + FDA simultaneously
A device sold globally needs three different compliance trails. Manual assembly is brutal.
Legacy device documentation
You ship a device for 10+ years. The original engineers are gone. The SBOM never existed in the first place.
How SBOMVault helps
01
FDA Premarket preset
Compliance preset that runs the same checks FDA reviewers run. Get a ready-to-submit packet.
02
Lifetime SBOM tracking
Track every shipped firmware version forever. New CVEs auto-mapped to affected device serials.
03
Multi-jurisdiction compliance
FDA, EU MDR, EU CRA, NTIA — single source of truth, multiple compliance exports.
04
Update mechanism documentation
The FDA wants to know how you'll patch a deployed device. We capture and surface that artifact.
05
VEX-aware compliance
Mark a CVE as not-exploitable in your context with a VEX statement that travels with the SBOM.
06
Tamper-evident audit logs
Every change to your compliance evidence is signed and logged. Audit-ready by default.
1 click
to export the SBOM section of a premarket submission from live data
Continuous
monitoring maps every new CVE to the devices that ship it
3
jurisdictions covered with one workflow (FDA, EU MDR, EU CRA)
Frequently asked questions
- Are SBOMs required for FDA premarket medical device submissions?
- Yes. The FDA's 2023 final guidance made SBOMs mandatory for premarket submissions, and the FDA has begun holding submissions that lack adequate SBOMs.
- How does SBOMVault handle post-market vulnerability tracking for shipped devices?
- Lifetime SBOM tracking follows every shipped firmware version, and newly discovered CVEs are auto-mapped to affected device serials so you can identify impacted devices quickly.
- Which jurisdictions does SBOMVault cover for medical devices?
- SBOMVault covers FDA, EU MDR, EU CRA, and NTIA as a single source of truth with multiple compliance exports.
- Can SBOMVault mark a CVE as not-exploitable for a medical device?
- Yes. You can mark a CVE as not-exploitable in your context using a VEX statement that travels with the SBOM.