Cybersecurity for Medical Devices: How to Meet FDA’s Latest Requirements.
The increasing connectivity of medical devices brings both innovation and risk. Cyber threats pose significant challenges, potentially affecting device functionality, patient safety, and data security. Recognising these risks, the U.S. Food and Drug Administration (FDA) has introduced stringent cybersecurity requirements for medical device manufacturers.
Ensuring compliance with the latest FDA regulations is crucial for manufacturers seeking market approval. This blog explores these requirements, detailing both premarket and postmarket expectations and offering best practices for maintaining compliance.
FDA Premarket Cybersecurity Requirements: A Comprehensive Breakdown
Cybersecurity is now a non-negotiable component of medical device design, and the FDA’s latest premarket cybersecurity regulations are a clear indicator of the industry’s heightened security expectations. The agency has significantly strengthened its cybersecurity requirements to ensure that medical devices remain secure throughout their entire lifecycle, from initial design to postmarket surveillance. Manufacturers must now demonstrate cybersecurity preparedness as a fundamental element of device safety and effectiveness.
Key Regulations and Guidance
The FDA’s updated guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”, was finalised in September 2023, replacing the 2018 draft guidance. The FDA began enforcing its new cybersecurity requirements on 1 October 2023, with full compliance reviews applying to all premarket submissions from 29 March 2024 onwards. This document reflects the FDA’s current stance on cybersecurity in medical devices, requiring manufacturers to integrate cybersecurity into the entire product lifecycle rather than treating it as a secondary concern.
Additionally, in March 2023, the U.S. Congress passed Section 524B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) under the Consolidated Appropriations Act of 2023, which mandates cybersecurity-related documentation in all premarket submissions for “cyber devices.” According to the law, a cyber device is defined as any medical device that:
Includes software, firmware, or programmable logic developed or authorized by the manufacturer.
Has network connectivity, either directly (e.g., Wi-Fi, Bluetooth, Ethernet) or indirectly (e.g., via another connected system).
Has technological characteristics that could be vulnerable to cybersecurity threats.
With this definition, nearly all modern medical devices fall under Section 524B, making compliance an industry-wide obligation. The law provides the FDA with the authority to reject non-compliant premarket submissions and enforce stricter cybersecurity controls.
Core Cybersecurity Expectations in Premarket Submissions
The FDA now requires manufacturers to provide extensive cybersecurity documentation with their 510(k), De Novo, or Premarket Approval (PMA) submissions. These expectations ensure that cybersecurity is embedded into device design, risk management, and ongoing maintenance.
1. Secure Product Development Framework (SPDF)
Manufacturers are expected to integrate security measures at every stage of product development, ensuring that devices are built with cybersecurity in mind from the outset. The Secure Product Development Framework (SPDF) is a structured methodology that incorporates security practices into the medical device development lifecycle, mirroring best practices from the software and IT security industries.
An SPDF includes:
Security-by-design principles that integrate cybersecurity into initial product architecture and planning.
Threat modeling to identify and mitigate potential attack vectors before development progresses.
Secure coding practices to reduce vulnerabilities in the software development phase.
Robust security testing, including penetration testing, fuzz testing, and static/dynamic analysis.
Postmarket cybersecurity maintenance, ensuring that devices remain secure after deployment.
By adopting an SPDF, manufacturers can ensure compliance with the FDA’s Quality System Regulation (21 CFR Part 820) and other industry standards, such as ISO 13485, IEC 62304, and UL 2900-2-1 (Cybersecurity for Network-Connectable Medical Devices).
2. Risk Management Documentation
Under FDA regulations, cybersecurity risk management is now an integral part of overall medical device risk management. Manufacturers must conduct comprehensive risk assessments and document their findings in accordance with:
ISO 14971 (Risk Management for Medical Devices).
FDA’s updated cybersecurity risk assessment model, which considers Exploitability Factors and Compensating Controls, in addition to Common Vulnerability Scoring System (CVSS) ratings.
The FDA requires manufacturers to:
Identify all potential cybersecurity threats that could impact patient safety and device functionality.
Assess the likelihood and severity of these threats using CVSS scores and hazard analysis methodologies.
Implement mitigations to reduce risks to an acceptable level, documented in a structured security risk management plan.
Establish ongoing risk evaluation processes to ensure security threats are continuously monitored and addressed throughout the product lifecycle.
3. Software Bill of Materials (SBOM)
The Software Bill of Materials (SBOM) is one of the most critical requirements under the new FDA guidance. The SBOM must provide a detailed inventory of all software components in a medical device, including:
First-party software (proprietary code developed by the manufacturer).
Third-party software (licensed components used in the device).
Open-source software (publicly available software integrated into the device).
Off-the-shelf (OTS) software (commercial software embedded in the device).
The SBOM must be:
Machine-readable to allow automated vulnerability scanning.
Regularly updated to reflect changes in software components.
Mapped to known vulnerabilities using databases like the National Vulnerability Database (NVD) or CISA’s Known Exploited Vulnerabilities (KEV) Catalog.
The FDA can reject a premarket submission if an SBOM is missing, incomplete, or outdated, as this would indicate an inability to manage cybersecurity risks effectively.
4. Vulnerability Disclosure and Patching Plan
To ensure ongoing security, manufacturers must submit a vulnerability disclosure and patching strategy outlining how they will:
Monitor and identify security vulnerabilities in both device firmware and external software dependencies.
Assess the severity of vulnerabilities based on risk impact (controlled vs. uncontrolled risks).
Provide timely software patches, ensuring that vulnerabilities are remediated within a defined timeframe (typically 60 days for high-severity threats).
Implement coordinated vulnerability disclosure (CVD) procedures, encouraging external security researchers to report vulnerabilities responsibly.
Beyond premarket submissions, manufacturers must comply with the FDA’s postmarket cybersecurity requirements, which include:
Routine cybersecurity monitoring and threat detection.
Timely remediation of vulnerabilities, ensuring that critical security patches are deployed within 60 days.
Compliance with the FDA’s 2016 Post market Cybersecurity Guidance, which remains in effect.
5. Security Architecture & Testing
The FDA expects manufacturers to provide detailed documentation of their device’s security architecture, including:
Data encryption for protecting sensitive patient information.
Access controls ensuring only authorized users can modify device settings.
Intrusion detection and prevention systems (IDS/IPS) for detecting cyberattacks.
Security testing results from penetration testing, fuzz testing, and vulnerability assessments.
The submission should include evidence of security control effectiveness, such as:
Traceability matrices linking identified risks to specific security mitigations.
Test reports from independent security audits.
Verification of security patches and firmware updates.
If a manufacturer cannot provide sufficient evidence of cybersecurity robustness, the FDA may issue a refuse-to-accept (RTA) decision, effectively blocking market entry.
Consequences of Non-Compliance
Failure to comply with the FDA’s cybersecurity requirements can result in:
Refusal to Accept (RTA) decisions, delaying market approvals.
Safety alerts, warning letters, or product recalls if a cybersecurity vulnerability is deemed a risk to patient safety.
Regulatory enforcement actions, including compulsory design modifications or restrictions on device sales
By integrating cybersecurity into the design, development, and maintenance of medical devices, manufacturers can not only achieve regulatory compliance but also enhance patient safety and operational reliability in the face of evolving cyber threats.
The FDA’s cybersecurity regulations are designed to future-proof medical devices, ensuring they remain secure throughout their entire lifecycle. Manufacturers that invest in robust cybersecurity measures will be well-positioned to comply with regulatory requirements and protect patients from emerging cyber risks.
Challenges in Implementing FDA Cybersecurity Requirements: A Deep Dive
The complexity of securing medical devices against cyber threats cannot be overstated. While the FDA’s latest cybersecurity regulations provide a clear roadmap for manufacturers, meeting these requirements is far from straightforward. Companies face a multitude of challenges, ranging from technical constraints to supply chain vulnerabilities and regulatory burdens. Addressing these obstacles is crucial for achieving compliance, ensuring patient safety, and maintaining market competitiveness.
1. Evolving Threat Landscape
One of the most significant challenges in medical device cybersecurity is the constantly shifting nature of cyber threats. Unlike traditional product safety concerns, which can often be addressed during development and remain stable over time, cybersecurity threats evolve continuously.
New vulnerabilities emerge daily: The rapid pace of software and firmware development introduces new security gaps that attackers can exploit.
Attack sophistication is increasing: Cybercriminals now use advanced AI-driven attacks, zero-day exploits, and ransomware that specifically target healthcare systems.
Healthcare is a prime target: Medical devices store and transmit sensitive patient data, making them lucrative targets for hackers. A breach could lead to data theft, ransomware attacks, or even patient harm.
Legacy devices remain vulnerable: Many healthcare providers still rely on older medical devices that were never designed with cybersecurity in mind, making them particularly susceptible to attacks.
Manufacturers must adopt a proactive approach by continuously monitoring for threats, patching vulnerabilities quickly, and staying informed about emerging cyber risks.
2. Integration into Device Development
Historically, medical device manufacturers have prioritised functionality and time-to-market over security. The need to release products quickly often leads to cybersecurity being treated as an afterthought rather than a core design requirement.
Engineering teams may lack cybersecurity expertise, leading to gaps in secure coding and architecture.
Security measures can conflict with usability, as stringent authentication protocols may complicate device operation for healthcare professionals.
Cybersecurity regulations are relatively new, meaning many manufacturers are still adapting to the need for security-by-design approaches.
Tension between innovation and compliance: Companies racing to launch new products may struggle to balance security requirements with business demands.
To overcome these challenges, manufacturers must embed cybersecurity into the product development lifecycle from the very beginning, adopting a Secure Product Development Framework (SPDF) to align with FDA and global cybersecurity best practices.
3. Technical Constraints: Securing Legacy and Resource-Limited Devices
Many medical devices are built on legacy systems that lack modern security capabilities. These devices, while still in use, often do not support:
Regular software updates or patches
Advanced encryption and authentication protocols
Secure boot and firmware integrity checks
Additionally, many medical devices have limited processing power and memory, making it challenging to implement robust security features without compromising performance.
Embedded medical devices, such as pacemakers or insulin pumps, have strict power and computational constraints, making it difficult to integrate real-time intrusion detection systems (IDS) or end-to-end encryption.
Retrofitting security into older devices is expensive and, in some cases, impossible due to hardware limitations.
To address these issues, manufacturers must:
Prioritise cybersecurity in new device development, ensuring that future devices are designed with security as a core feature.
Implement hardware-based security solutions, such as trusted platform modules (TPMs) for secure boot processes.
Adopt risk-based segmentation strategies, where legacy devices are isolated from critical hospital networks to reduce exposure to cyber threats.
4. Supply Chain Management: Tracking Third-Party Software Vulnerabilities
A major cybersecurity challenge in medical devices is the complexity of software supply chains. Most modern devices rely on third-party software, open-source components, and off-the-shelf (OTS) software, which introduces additional risk:
Third-party vendors may not follow strict cybersecurity protocols, creating vulnerabilities that impact the entire device.
Open-source software (OSS) may contain unpatched security flaws that hackers can exploit.
Software Bill of Materials (SBOM) management is challenging, requiring continuous tracking of all software components, versions, and patch statuses.
Without rigorous supply chain security, manufacturers may unknowingly introduce vulnerabilities into their devices. To mitigate this risk, companies must:
Enforce strict cybersecurity requirements on third-party vendors and require regular security audits.
Implement real-time SBOM tracking to detect vulnerabilities in external components before they become exploitable.
Use automated software composition analysis (SCA) tools to monitor third-party software dependencies.
5. Regulatory Burden: The Cost of Compliance
Meeting FDA cybersecurity requirements is resource-intensive, requiring:
Extensive documentation detailing cybersecurity risk management, testing, and mitigation strategies.
Rigorous security testing, including penetration testing, fuzz testing, and vulnerability assessments.
Ongoing compliance with evolving regulations, which require frequent updates to cybersecurity protocols.
Small and mid-sized manufacturers may struggle with the cost and expertise required to maintain compliance, leading to:
Increased time-to-market as security requirements are integrated.
Financial strain, as cybersecurity investments compete with other business priorities.
Regulatory uncertainty, as companies navigate evolving FDA guidance and global cybersecurity laws.
To streamline compliance, manufacturers should invest in automated security testing tools, align with international cybersecurity standards, and establish cross-functional teams that integrate regulatory, engineering, and cybersecurity expertise.
Best Practices for Compliance: A Proactive Approach
Successfully navigating the FDA’s cybersecurity landscape requires a holistic strategy that prioritises security throughout the entire device lifecycle.
1. Security-By-Design Approach
Implement a Secure Product Development Framework (SPDF) to embed security into every stage of development.
Conduct threat modelling and risk assessments early and often.
Follow established industry standards such as ISO 14971, IEC 62304, and UL 2900-2-1 to meet global security expectations.
2. Rigorous Security Testing
Perform static code analysis, penetration testing, and software composition analysis to identify and mitigate vulnerabilities before release.
Establish a cybersecurity testing framework that includes fuzz testing and attack simulations to validate security controls.
3. Effective Vulnerability Management
Develop a postmarket cybersecurity monitoring program to detect vulnerabilities in real time.
Engage in coordinated vulnerability disclosure (CVD) to collaborate with security researchers and improve transparency.
4. Software Updates and Patch Management
Design devices with secure update capabilities (e.g., over-the-air (OTA) updates for networked devices).
Implement a patch management strategy that complies with FDA postmarket cybersecurity guidelines, ensuring critical vulnerabilities are remediated within 60 days.
5. Industry Collaboration and Information Sharing
Join Information Sharing and Analysis Organizations (ISAOs) to stay informed about the latest cyber threats.
Maintain open communication with regulators and healthcare providers to coordinate cybersecurity risk management.
Conclusion: A Cybersecurity-First Future
Cybersecurity for medical devices is no longer optional—it is a regulatory requirement and a critical patient safety concern. The FDA’s latest regulations demand a proactive approach, ensuring that cybersecurity is integrated into both premarket submissions and postmarket management.
Manufacturers that embrace a comprehensive security strategy will not only meet regulatory expectations but also build trust with healthcare providers and patients. By following best practices, investing in continuous improvement, and maintaining transparency, the industry can strengthen the security of medical devices and safeguard patient health in an increasingly connected world.
With cyber threats growing more sophisticated, only companies that prioritise security-by-design will be positioned for long-term success in the rapidly evolving medical device landscape.