FDA Section 524B compliance for medical device startups.Medical Device Cybersecurity. Start to submission.
MedSecure USA produces the complete FDA cybersecurity documentation package your device submission requires without hiring a full security team.
All 12 documents, fixed pricing, 6–8 week delivery.
Current on the February 2026 FDA Final Guidance.
The problem device startup teams hit too late.
The FDA's updated February 2026 Final Guidance requires a complete cybersecurity file for every connected medical device submission
Missing documentation triggers a Refuse to Accept letter and your submission doesn't get reviewed until these gaps are identified and mediated with supporting documentation
For any cyber device submission under Section 524B, the FDA expects a complete cybersecurity file including:Security Risk Management Plan (SRMP)
Threat Model & Security Architecture Report
Security Architecture Views (4 required)
Software Bill of Materials - machine-readable (CycloneDX/SPDX)
SBOM Known Vulnerability Assessment
Security Risk Management Report (SRMR)
SOUP / OTS Software Assessment
Penetration Testing Report
Cybersecurity Labeling Additions
Vulnerability Disclosure Policy (VDP)
Post-Market Cybersecurity Monitoring Plan
Coordinated Vulnerability Disclosure (CVD) PolicyMedSecure delivers all 12