What Are FDA Cybersecurity Regulations?
The FDA cybersecurity framework applies to medical devices that connect to networks, communicate with other devices, or store/transmit patient data. The regulations require:
- ✔ Secure-by-design development – Cybersecurity must be embedded throughout the product lifecycle.
- ✔ Risk-based security controls – Devices must be resilient against cyber threats.
- ✔ Software Bill of Materials (SBOM) – Transparency in third-party software components.
- ✔ Incident response and patch management – Manufacturers must ensure timely security updates.
- ✔ Pre-market & post-market compliance – Ongoing risk monitoring and regulatory reporting.
Failure to comply can result in regulatory delays, product recalls, liability risks, and reputational damage.