FDA Cybersecurity Guidance for Medical Devices

The U.S. Food and Drug Administration (FDA) has issued updated guidance titled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (June 27, 2025). This document outlines the FDA’s latest recommendations for ensuring that medical devices are designed and maintained with robust cybersecurity measures to protect patient safety and device effectiveness throughout the product lifecycle.

Key Highlights

• Cybersecurity as Safety: The FDA emphasizes that cybersecurity is integral to device safety and is a required aspect of the Quality System Regulation (21 CFR Part 820), with specific emphasis on design and risk analysis¹. This aligns with the FDA’s recent final rule to amend its Quality System Management Regulation—more details can be found in our news article on the FDA Final Rule update.
• Secure Product Development Framework (SPDF): Manufacturers are encouraged to implement SPDFs to proactively identify and mitigate cybersecurity risks, e.g., vulnerabilities in products, throughout device design, development, and postmarket phases.
• Premarket Submission Requirements: The guidance provides detailed expectations for including cybersecurity-related documentation in all premarket submissions, including 510(k), De Novo, PMA, and IDE applications.
• Cyber Devices² under FDORA 2022³ (Section 524B): Devices that include software, are internet-connected, and are potentially vulnerable to cybersecurity threats must meet new statutory requirements, including the submission of:
  • Cybersecurity risk management plans
  • Plans to monitor and address postmarket vulnerabilities
  • A Software Bill of Materials (SBOM)
• Security by Design: FDA highlights the importance of designing devices with embedded security controls addressing authentication, authorization, encryption, data integrity, event logging, and secure updates.
• Transparency and Labeling: Manufacturers should ensure users have access to cybersecurity-related information necessary to integrate, configure, and maintain device security within the broader healthcare environment.

This guidance replaces previous versions and reflects the evolving cybersecurity threat landscape, offering a harmonized approach aligned with international standards such as ISO 13485, IMDRF guidance, and risk management best practices.

How MedEnvoy Supports Compliance

At MedEnvoy, we help medical device manufacturers ensure compliance with the FDA’s latest cybersecurity expectations by offering:

• Regulatory Strategy & Gap Assessments: Evaluating your current development and documentation practices against FDA and FDORA cybersecurity requirements.
• Cybersecurity Documentation Support: Assisting in the preparation of premarket submissions, including Security Risk Management Reports, Threat Models, Cybersecurity Risk Assessments, and SBOMs.
• Secure Product Development Framework (SPDF) Implementation: Advising on the integration of SPDF principles into your quality system and product development lifecycle in alignment with ISO 13485 and FDA expectations.

1. On Feb 2, 2026 the majority of the Quality System Regulation will be withdrawn, and the updated regulation will incorporate reference to ISO 13485:2016. ↩︎
2. A “Cyber Device”, per FDA, is a device that “(1) includes software validated, installed, or authorized by the sponsor as a device or in a device; (2) has the ability to connect to the internet; and (3) contains any such technological characteristics validated, installed, or authorized by the sponsor that could be vulnerable to cybersecurity threats” (Section 524B(c) of the FD&C Act). ↩︎
3. Food and Drug Omnibus Reform Act of 2022. ↩︎

If you have any questions regarding the above, we encourage you to reach out to our regulatory experts here.