Complying with FDA Cybersecurity Requirements for Medical Devices

The healthcare technology is evolving and the integration of networked medical devices has become indispensable in patient care. These devices, ranging from insulin pumps and eye scanners to MRI machines, offer innovative solutions to medical challenges. However, with the benefits of connectivity and digitalisation come inherent risks, particularly in terms of cybersecurity. Recognising this, regulatory bodies such as the U.S. Food and Drug Administration (FDA) have established strict requirements to ensure the safety and security of medical devices.


FDA requires a cybersecurity strategy for every new medical device submission which includes detailed procedures for monitoring, updating, patching, and remedying the devices. Applicants must prove assurance regarding the security of the device and associated systems. A comprehensive Software Bill of Materials (SBOM) document must be provided. This document should detail the code, including commercial, open-source, and off-the-shelf components, used in the device's functionalities.

Let's list the key requirements for complying with FDA cybersecurity regulations for networked Medical Devices, Software as a Medical Device and Medical Devices that include software.

1) Security Risk Management: The FDA emphasises a risk-based approach to cybersecurity, requiring manufacturers to identify and assess potential risks associated with their medical devices. This involves conducting thorough risk assessments throughout the device's lifecycle, from design and development to post-market surveillance. Manufacturers must implement risk mitigation strategies to address identified vulnerabilities and ensure the security of their devices.
2) Documentation: Documentation plays a crucial role in demonstrating compliance with FDA cybersecurity requirements. Manufacturers are expected to maintain comprehensive records detailing their cybersecurity risk management processes, including risk assessments, mitigation measures, and any changes or updates made to enhance device security. Moreover, the security testing documentation (penetration testing and infrastructure assessment) including Test Plans, Test Protocols, Technical Reports with the remediation strategy and the Test Summary Report should be provided to facilitate any concerns raised by FDA.
3) Software Bill of Materials (SBOM): as part of the documentation package, manufacturers must provide SBOM that includes details of commercial, open-source, and off-the-shelf components your team used to build the device’s functionality.
4) Design Controls: Integrating cybersecurity considerations into the design and development of medical devices is paramount. FDA expects manufacturers to implement robust design controls that address cybersecurity risks from the outset. This includes incorporating security features such as encryption, authentication, and access controls to safeguard sensitive data and prevent unauthorised access to the device. This should be highlighted in the Secure Product Development Framework (SPDF).
5) Software Validation and Testing: Software validation and testing are critical components of FDA cybersecurity requirements for medical devices. Manufacturers must conduct thorough testing to ensure the security and functionality of the device's software components. This includes vulnerability assessments, penetration testing, and validation of security controls to identify and address potential weaknesses that could be exploited by malicious actors. The testing must be performed by certified security professionals to prove the competency.
6) Incident Response Plan: Preparedness is key in effectively responding to cybersecurity incidents and data breaches. FDA expects manufacturers to have robust incident response plans in place, outlining procedures for detecting, reporting, and mitigating security incidents. Manufacturers should regularly review and update their incident response plans to adapt to evolving cyber threats and ensure timely and effective responses.

Complying with FDA cybersecurity requirements for medical devices is imperative to ensure the safety, effectiveness, and security of healthcare technology.
And if you require assistance with cybersecurity testing for your device, our team would be thrilled to assist. We provide all the cyber security-related documentation required for your submission. With us, you will be confident that the device will not be rejected because of security concerns.
Just book a free consultation by clicking the link below where we can discuss the approach in detail.