How the FDA Prioritizes Cybersecurity in Device Submissions
As medical devices become more interconnected, cybersecurity has moved from a technical consideration to a central pillar of patient safety and regulatory compliance. The FDA has made clear: cybersecurity is not optional. It is a decisive factor in determining whether a device is considered safe and effective for market approval.
Why Cybersecurity Matters
Today’s medical devices collect, store, transmit, and process sensitive patient data—and their environments of use vary widely. Whether connected in a hospital, a physician’s office, or used by patients at home, cybersecurity risks are ever-present. The environment of use shapes the cybersecurity process, dictating which vulnerabilities are most likely and which safeguards are most critical. Any weakness can lead to unauthorized access, device malfunction, or even patient harm. That’s why cybersecurity is woven into the FDA’s submission review process.
FDA’s Priorities in Cybersecurity Review
When evaluating submissions, the FDA prioritizes cybersecurity in the following ways:
Design Controls from the Start
Cybersecurity must be built into product design from day one—not bolted on at the end. The FDA expects a risk-based approach that aligns with Quality System Regulation (21 CFR Part 820) and ISO 14971 risk management standards.Threat Modeling & Risk Assessment
Sponsors must show they have identified and evaluated threats, vulnerabilities, and associated risks, along with mitigation strategies that protect device function and patient safety.Risk Mitigation & Controls
The FDA expects sponsors to implement practical protections such as encryption, authentication, access restrictions, and secure coding practices. These risk mitigations and controls must be clearly documented in the submission.Postmarket Cybersecurity Management
The FDA emphasizes lifecycle security. Sponsors must provide plans for ongoing monitoring, coordinated vulnerability disclosure, and timely patch deployment.Transparency & Labeling
Clear labeling should communicate cybersecurity features, update procedures, and the responsibilities of both manufacturers and users.
How Sponsors Can Prepare
To meet FDA expectations and avoid costly delays:
Develop cybersecurity testing protocols early in development.
Document all security measures in submissions (510(k), De Novo, PMA).
Prepare a Software Bill of Materials (SBOM) to track third-party components.
Establish a vulnerability disclosure and response program.
Align documentation with FDA guidance, including the 2025 Premarket Cybersecurity Guidance.
By embedding cybersecurity into every stage of development, sponsors not only meet regulatory requirements but also build patient and provider trust—positioning themselves competitively in a connected healthcare ecosystem.
Cybersecurity isn’t just a compliance hurdle—it’s a competitive advantage.
At NMCG, we help clients design and document cybersecurity measures that meet FDA expectations and support global submissions.
