Cybersecurity is no longer an optional consideration for medical device manufacturers—it's a fundamental regulatory requirement.
With the addition of Section 524B ("Ensuring Cybersecurity of Devices") to the Federal Food, Drug, and Cosmetic Act, the FDA significantly strengthened cybersecurity expectations for connected medical devices, Software as a Medical Device (SaMD), mobile health applications, and AI-enabled technologies.
Yet many manufacturers continue to rely on outdated cybersecurity practices, creating documentation gaps that can delay FDA submissions or trigger Refuse to Accept (RTA) determinations.
What Is Section 524B?
Section 524B expanded the FDA's authority to require cybersecurity information in premarket submissions for qualifying cyber devices, including:
- 510(k)s
- De Novo Requests
- Premarket Approval (PMA) applications
Manufacturers must now demonstrate they have processes to:
- Identify and assess cybersecurity vulnerabilities
- Manage and mitigate cybersecurity risks
- Monitor vulnerabilities throughout the product lifecycle
- Maintain secure software update processes
- Support coordinated vulnerability disclosure
Since these requirements took effect, the FDA has increasingly refused to accept submissions that lack adequate cybersecurity documentation.
Cybersecurity Is Now a Lifecycle Requirement
Perhaps the most significant change is the FDA's shift from evaluating cybersecurity as a one-time submission activity to treating it as a continuous lifecycle process.
Cybersecurity now extends far beyond penetration testing or a standalone risk assessment. Manufacturers are expected to maintain documented processes for:
- Continuous vulnerability monitoring
- Postmarket cybersecurity risk management
- Security patch and software update management
- Incident response
- Ongoing software maintenance
Cybersecurity is no longer something you complete before submission—it's an ongoing responsibility throughout the life of the device.
FDA Expects More Comprehensive Documentation
Section 524B has substantially increased the level of cybersecurity evidence expected during regulatory review.
Typical submission documentation now includes:
- Cybersecurity risk assessments
- Threat modeling
- Secure Software Development Lifecycle (SSDLC) documentation
- Software Bill of Materials (SBOM)
- Penetration testing reports
- Vulnerability management plans
- Postmarket cybersecurity monitoring plans
For many organizations, this represents a significant expansion of both documentation and development activities.
Connected Devices and SaMD Face Increased Scrutiny
The greatest impact has been on products that rely on software or network connectivity, including:
- Connected medical devices
- Software as a Medical Device (SaMD)
- Mobile health applications
- Cloud-connected platforms
- AI-enabled technologies
- Remote patient monitoring systems
These products frequently incorporate wireless communications, cloud services, third-party software components, and regular software updates—all of which introduce cybersecurity risks that must be identified, documented, and managed from the earliest stages of development.
FDA reviewers increasingly expect cybersecurity to be built into the design process—not added just before submission.
Cybersecurity Is Part of the Quality Management System
Cybersecurity is no longer viewed as a standalone engineering function. It is now expected to be fully integrated into a manufacturer's Quality Management System (QMS).
This includes alignment with:
- Design Controls
- Risk Management
- Change Control
- CAPA
- Supplier Management
- Complaint Handling
- Postmarket Surveillance
Organizations that separate cybersecurity from their quality processes often encounter unnecessary regulatory challenges and remediation efforts.
Common Cybersecurity Gaps
At RQMIS, we frequently see manufacturers struggle with:
- Missing or incomplete SBOMs
- Weak threat modeling
- Limited software traceability
- Undocumented vulnerability management processes
- Cybersecurity introduced too late in development
- Poor linkage between cybersecurity risks and verification activities
- Inadequate postmarket monitoring plans
These deficiencies often require significant rework late in development, increasing both cost and submission timelines.
Build Cybersecurity Into Development—Not Submission
The most successful manufacturers incorporate cybersecurity from the beginning of product development, including:
- Software architecture
- System design
- Supplier selection
- Risk management
- Verification and validation planning
Waiting until submission preparation to address cybersecurity rarely provides enough time to develop the documentation and processes the FDA now expects.
Final Thoughts
Section 524B fundamentally changed how the FDA evaluates cybersecurity.
Today, cybersecurity is a core component of product safety, quality, risk management, and regulatory compliance—not simply an IT or engineering concern.
Organizations that integrate cybersecurity throughout product development are better positioned to:
- Reduce submission delays
- Improve FDA review readiness
- Minimize costly remediation
- Strengthen long-term product security and compliance
The companies best prepared for future regulatory expectations are those that treat cybersecurity as a foundational element of product development—not a last-minute compliance exercise.
Need a Cybersecurity Gap Assessment?
RQMIS helps medical device, IVD, SaMD, AI-enabled, and connected device manufacturers strengthen cybersecurity throughout the product lifecycle.
Our cybersecurity services include:
- Cybersecurity Gap Assessments
- FDA Cybersecurity Submission Readiness
- Threat Modeling
- Penetration Testing
- Software Bill of Materials (SBOM) Development
- Secure Software Development Lifecycle (SSDLC) Support
- Cybersecurity Risk Management
- Postmarket Cybersecurity Planning
If you're preparing for an FDA submission, our team can evaluate your cybersecurity program, identify documentation gaps, and help ensure your product is ready before those gaps become costly submission delays.