All phases
Journey phase
Submission
FDA review, deficiencies, and clearance.
3 guides · 24 curated tips
Your journey progress
1 of 5 phases explored · saved on this device
What to focus on
Topics for the submission phase
6 tips
Overview
Start here. The big picture for MedTech security.
8 tips
Premarket
Submit a cybersecurity package the FDA will accept.
10 tips
FDA Response
Turn an FDA cybersecurity hold into a clean clearance.
Related resources
Checklists for submission and adjacent phases
Premarket · 6 min read
FDA Premarket Cybersecurity Submission Checklist
Section-by-section checklist mirroring FDA's RTA cybersecurity items: security risk management, SBOM, threat model, testing evidence, labeling, and CVD policy.
SBOM · 5 min read
SBOM Quality & VEX Readiness Checklist
What every cybersecurity reviewer (FDA or hospital) looks for in an SBOM: format, depth, signatures, hashes, supplier identification, and paired VEX statements.
Postmarket · 7 min read
Postmarket Vulnerability Response Template
A working PSIRT playbook: intake, triage with CVSS + clinical impact, communication, fix, regulatory reporting, and lessons-learned loop.