FDA Cybersecurity Compliance Standards: 2025 Complete Guide
- Beng Ee Lim
- Jul 14
- 8 min read
Updated: Sep 7
FDA's new cybersecurity compliance standards carry criminal penalties and RTA threats that can destroy medical device companies. With the June 2025 final guidance making cybersecurity violations federally prosecutable, most of MedTech still doesn't understand the "cyber device" definition that determines their regulatory fate and survival.
Quick Answer FDA cybersecurity compliance standards require cyber devices to submit security risk management plans, Software Bills of Materials (SBOMs), and vulnerability monitoring procedures under FDORA Section 524B. Violations are now criminal offenses with FDA issuing RTA letters for non-compliance. Cyber devices include any medical device with software that can connect to internet, including Bluetooth, USB, or Wi-Fi capabilities.
This guide reveals the exact cybersecurity compliance standards that protect your company from criminal prosecution while ensuring regulatory approval in the new enforcement era.
URGENT: Check Your Cyber Device Status Immediately
THESE GAPS CAN TRIGGER CRIMINAL LIABILITY:
Missing cybersecurity documentation in premarket submissions
Inadequate vulnerability monitoring plans for marketed devices
Incomplete Software Bills of Materials (SBOMs) submissions
Failure to provide the required cybersecurity information
FDORA Section 524B makes cybersecurity non-compliance a prohibited act under the FD&C Act. While the FD&C Act has always allowed DOJ to pursue criminal action for shipping adulterated or misbranded devices, Section 524B makes a non-compliant cyber device adulterated/misbranded, enabling criminal charges for cybersecurity violations.
If your device qualifies as a "cyber device," non-compliance can result in federal criminal charges under existing adulteration/misbranding statutes.
What Are FDA Cybersecurity Compliance Standards?
FDA cybersecurity compliance standards are mandatory requirements under the Food and Drug Omnibus Reform Act (FDORA) that ensure medical devices with cybersecurity risks meet specific security protocols throughout their lifecycle. These standards became enforceable on March 29, 2023, with FDA issuing RTA (Refuse to Accept) letters since October 1, 2023.
The Legal Foundation: FDORA Section 524B
On December 29, 2022, the Consolidated Appropriations Act, 2023 ("Omnibus") was signed into law. Section 3305 of the Omnibus -- "Ensuring Cybersecurity of Medical Devices" -- amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding section 524B, Ensuring Cybersecurity of Devices.
Critical Understanding: This new statutory provision makes it a prohibited act to fail to comply with FDA cybersecurity requirements, enabling criminal prosecution and injunctive relief.
What Makes a Device Subject to These Standards
Cyber Device Definition (Section 524B(c)): A device that:
Includes software validated, installed, or authorized by the sponsor as a device or in a device
Has the ability to connect to the internet
Contains technological characteristics that could be vulnerable to cybersecurity threats
Expanded Internet Connection Definition: FDA considers the "ability to connect to the internet" to include devices that are able to connect to the internet, whether intentionally or unintentionally, through any means. This includes:
Network, server, or cloud service provider connections
Radio-frequency communications (Wi-Fi, cellular, Bluetooth, Bluetooth Low Energy)
Hardware connectors capable of connecting to the internet (USB, ethernet, serial port)
The June 2025 Final Guidance: What Changed Everything
Latest Cybersecurity Compliance Requirements
On June 26, 2025, the FDA issued the final guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions." This guidance adds Section VII to address FDA's recommendations regarding section 524B of the FD&C Act for cyber devices.
Major Changes in 2025 Guidance:
Explicit cybersecurity assurance requirement: Manufacturers must demonstrate a reasonable assurance of cybersecurity of their cyber device
Expanded cyber device scope: If a device contains software, the guidance applies, whether or not it is network-enabled
Enhanced substantial equivalence impact: Increased cyber risks can affect 510(k) substantial equivalence determinations
Criminal Enforcement Reality
Prohibited Act Status: Section 524B creates a new prohibited act prohibiting "the failure to comply with any requirement under section 524B(b)(2) (relating to ensuring device cybersecurity.)"
Enforcement Mechanism: By making non-compliant cyber devices adulterated/misbranded under the FD&C Act, existing criminal prosecution authority (21 U.S.C. § 331-333) can be applied to cybersecurity violations. While no new criminal offense was created, cybersecurity non-compliance now falls under established federal prosecution pathways.
The Three Core Cybersecurity Compliance Standards
Standard 1: Vulnerability Monitoring Plan
Requirement: Submit a plan to monitor, identify, and address, as appropriate, in a reasonable time, postmarket cybersecurity vulnerabilities and exploits, including coordinated vulnerability disclosure and related procedures.
What This Means: You must have documented procedures for:
Continuous monitoring of cybersecurity threats
Vulnerability identification processes
Response timelines for addressing exploits
Coordinated disclosure protocols with security researchers
Standard 2: Cybersecurity Assurance Processes
Requirement: Design, develop, and maintain processes and procedures to provide a reasonable assurance that the device and related systems are cybersecure, and make available postmarket updates and patches to the device and related systems.
What This Means: You must demonstrate:
Secure Product Development Framework (SPDF) implementation
Cybersecurity risk management throughout product lifecycle
Capability to deliver security updates and patches
Ongoing cybersecurity maintenance procedures
Standard 3: Software Bill of Materials (SBOM)
Requirement: Provide a software bill of materials, including commercial, open-source, and off-the-shelf software components.
What This Means: You must document:
All software components in your device
Third-party and open-source dependencies
Version information for all components
Known vulnerabilities in included software
Secure Product Development Framework (SPDF): The Core Standard
What Is SPDF?
FDA recommends implementation and adoption of a "Secure Product Development Framework" or "SPDF," defined as a set of processes that reduce the number and severity of cybersecurity vulnerabilities throughout the product lifecycle.
SPDF Core Components:
Security Risk Management
Security Architecture
Cybersecurity Testing
Security Risk Management Requirements
Cybersecurity Risk Assessment: The guidance recognizes that risks related to cybersecurity are hard to predict and that the likelihood of a breach happening may not be estimated or quantified using past information or simulation.
Required Documentation:
Cybersecurity risk management strategy for the device
Documentation of medical device cybersecurity risk assessments
Security controls implementation
Testing outcomes and validation results
Security Architecture Standards
Eight Control Categories Required:
Device identification and authentication
Authorization and access control
Data protection and integrity
System integrity
Malware detection and protection
Secure communications
System security monitoring
Configuration management
Architecture Documentation: "Draw us a picture." FDA wants to see the global system view, the multi-patient harm view, updateability, and security control implementation.
Cybersecurity Testing Requirements
Testing Types Required:
Threat modeling validation
Vulnerability scanning
Penetration testing
Secure configuration testing
Update mechanism validation
The RTA Threat: How Non-Compliance Destroys Companies
What Is an RTA Letter?
FDA has been issuing refuse to accept (RTA) letters when manufacturers submit a "cyber device" that does not meet the new cybersecurity requirements. An RTA means that the FDA won't carry out a review of a submission for a new medical device, because it did not meet the basic cybersecurity requirements or has any missing information.
RTA Triggers
Common RTA Causes:
Missing required cybersecurity documentation
Inadequate vulnerability monitoring plans
Incomplete SBOM submissions
Failure to demonstrate cybersecurity assurance
Insufficient SPDF implementation evidence
Business Impact of RTA
Immediate Consequences:
Complete halt of regulatory review process
Market access delays costing millions
Investor confidence destruction
Competitive disadvantage while fixing compliance
Long-term Damage:
Regulatory reputation harm affecting future submissions
Customer trust erosion in cybersecurity capabilities
Potential criminal liability exposure
Industry-Specific Cybersecurity Compliance Standards
AAMI Standards Integration
ANSI AAMI SW96 has been a recognized consensus standard for the last two years, but industry adoption has been arguably slow. The explicit reference to SW96 provides manufacturers with more formal, normative requirements.
Historical Approach vs. New Requirements:
Previous: Blend of ISO 14971 (safety risk) and AAMI TIR 57 (security risk)
Current: Formal SW96 compliance with explicit FDA cybersecurity requirements
International Harmonization
The guidance aligns with the International Medical Device Regulators Forum (IMDRF) "Principles and Practices for Medical Device Cybersecurity, March 2020", reinforcing global efforts for requirement harmonization.
Global Impact: Companies must meet US cybersecurity compliance standards while considering international regulatory alignment.
Third-Party Software Component Compliance
Special Requirements for Third-Party Components
The use of third-party software components in medical devices requires thorough cybersecurity risk assessment and management.
Third-Party Component Documentation:
Complete SBOM for all components
Vulnerability assessments for each component
Update procedures for third-party software
Supply chain cybersecurity risk management
Open Source Software Challenges
Compliance Complications:
Open source components may lack vendor support
Vulnerability disclosure timelines vary by project
Update availability depends on community maintenance
License compliance adds complexity
Cybersecurity Compliance for Device Modifications
When Changes Trigger New Requirements
For manufacturers implementing changes to devices already placed on the market, changes that impact a device's security posture may trigger new submission requirements.
Change Categories:
Likely to impact cybersecurity: Require full compliance documentation
Unlikely to impact cybersecurity: Reduced documentation requirements
Security-enhancing changes: May require demonstration of continued assurance
Documentation Requirements for Modifications
Required Evidence:
Revised threat modeling documentation
Clear evidence that device remains resilient in dynamic threat environment
Updated vulnerability management procedures
Enhanced security control implementation
Interoperability and Cybersecurity Compliance
Balancing Security and Interoperability
Implementing cybersecurity controls should facilitate safe and effective information exchange without unnecessarily complicating or hindering device interoperability.
Compliance Considerations:
Cybersecurity risks associated with interoperable functionality must be assessed
Connections with other medical devices require security evaluation
Healthcare infrastructure integration needs security controls
General-purpose computing platform connections require protection
Multi-Device Security Standards
System-Level Requirements:
Network security assumptions documentation
Multi-patient harm prevention measures
Cross-device communication security
Healthcare facility integration protection
Protect Your Company from Criminal Cybersecurity Violations
The Bottom Line: FDA cybersecurity compliance standards aren't optional recommendations—they're mandatory requirements with criminal penalties for violations. Companies that master these standards demonstrate regulatory sophistication while avoiding devastating RTA letters and potential prosecution.
Remember: In today's regulatory environment, cybersecurity compliance isn't just about preventing hacks—it's about preventing criminal prosecution, RTA letters, and business destruction.
The companies that treat cybersecurity compliance standards as strategic imperatives rather than technical checkboxes will dominate markets while others face the devastating consequences of federal enforcement actions.
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Frequently Asked Questions
What devices qualify as "cyber devices"?
Any device that includes software and has the ability to connect to the internet, whether intentionally or unintentionally. This includes devices with Bluetooth, Wi-Fi, USB ports, or any network connectivity capability.
When do cybersecurity requirements apply?
Manufacturers of cyber devices are required to submit cybersecurity information starting March 29, 2023, in premarket submissions including 510(k), PMA, PDP, De Novo, or HDE. This includes supplements and abbreviated submissions.
What happens if I submit without required cybersecurity documentation?
Beginning October 1, 2023, FDA expects cyber device submissions to contain all required cybersecurity information. Missing documentation results in RTA letters and complete review suspension.
Can cybersecurity risks affect substantial equivalence?
Yes. When evaluating if a device is substantially equivalent to a predicate, if the subject device is determined to have increased cyber risks, the FDA may determine the subject device is not substantially equivalent.
What is a Software Bill of Materials (SBOM)?
An SBOM documents all software components in your device, including commercial, open-source, and off-the-shelf software. It must align with the 2021 National Telecommunications and Information Administration (NTIA) SBOM Framing Document.
How do I demonstrate "reasonable assurance of cybersecurity"?
Through comprehensive SPDF implementation, including security risk management, security architecture with eight control categories, and cybersecurity testing throughout the product lifecycle.
What are the criminal penalties for non-compliance?
FDORA makes cybersecurity requirement violations a prohibited act under the FD&C Act, enabling criminal prosecution and injunctive relief. Specific penalties depend on violation severity and impact.
Do international devices need US cybersecurity compliance?
Yes. Any device marketed in the US must meet FDA cybersecurity compliance standards regardless of manufacturer location or international approvals.