FDA expects Software as a Medical Device (SaMD) manufacturers to address cybersecurity risks as part of premarket submissions. However, many teams struggle to interpret what FDA expects in practice—especially in early and growth stages.
This white paper provides a practical, FDA-aligned approach to cybersecurity readiness for SaMD products. It helps manufacturers understand how to identify cybersecurity risks, document controls, and present evidence in a way that supports FDA review without slowing development.
- FDA cybersecurity expectations for SaMD premarket submissions
- How cybersecurity ties directly to patient safety
- Common gaps that delay FDA approval
- Practical documentation approaches regulators expect
- SaMD founders and product leaders
- Regulatory and quality teams
- Security and engineering teams preparing for FDA submission