How Post-Quantum Readiness Aligns with FDA Expectations for Medical Devices

Blog 2: How Post-Quantum Readiness Aligns with FDA Expectations for Medical Devices

In our first blog, we introduced post-quantum cryptography (PQC) and why long-lived connected medical devices are uniquely vulnerable to emerging threats from quantum computing.

In this post, we’ll dig deeper into the regulatory perspective - and explain how cryptographic flexibility and planning for future standards align with current FDA cybersecurity expectations.

The FDA’s Focus on Cryptography and Lifecycle Security

The FDA’s 2023 Premarket Cybersecurity Guidance outlines the need for medical devices to be secure by design - with protections that remain effective throughout the device’s full lifecycle.

Core expectations include:

• Implementing cryptographic protections (for confidentiality, integrity, authentication)
• Supporting secure update mechanisms to maintain protections over time
• Documenting the device’s security architecture, risk management, and testing

These expectations are reinforced in Section 524B of the FD&C Act, which requires that submissions for certain cyber devices include “reasonable assurance” that protections will remain effective in the face of evolving threats.

So What Does This Mean for PQC?

While the FDA does not currently require use of post-quantum algorithms, it does expect device makers to:

• Understand the cryptographic mechanisms currently in use
• Be able to update or replace those mechanisms as needed
• Demonstrate a plan for cryptographic evolution, especially for devices that will remain on the market for 10–15+ years

This is where crypto-agility becomes essential.

Crypto-agility is the ability to change or upgrade cryptographic algorithms without redesigning the entire device or disrupting its secure functionality.

Key FDA-Aligned Practices for Post-Quantum Readiness

1. Cryptographic Visibility (Design Documentation)

The 2023 guidance (Section VI.A) calls for manufacturers to describe how cryptography is used to implement confidentiality, integrity, and authentication in:

• Secure boot
• Software/firmware updates
• Communication protocols
• Data storage

While the FDA doesn’t mandate a “cryptographic inventory,” many device makers are using Cryptographic Bills of Materials (CBOMs) - internal tools to track:

• Algorithms in use
• Key types and lengths
• Usage context (e.g., transport, storage, OTA updates)

CBOMs are not required but are increasingly viewed as a best practice to support submission clarity and audit readiness.

2. Agility and Updatability (Section VI.D)

FDA guidance expects devices to support secure updates over time - including the ability to:

• Patch or replace cryptographic libraries
• Rotate keys and certificates
• Adapt to new algorithms as threats evolve

This requirement aligns directly with PQC planning, as legacy crypto (like RSA and ECC) will eventually need to be phased out in favor of quantum-resistant algorithms.

3. Documenting Your Strategy (System-Level View)

The FDA expects a system-level approach to cybersecurity. Your documentation should show:

• Cryptographic choices made during design
• Testing procedures used to validate those choices
• How your update mechanisms support ongoing security
• Risk-based rationale for lifecycle cryptographic planning

This is not about predicting the future - it's about showing that your architecture is flexible enough to adapt when change comes.

What About Legacy Devices?

Devices already in the field present a serious challenge. Many were not designed for cryptographic updates and may:

• Use hardcoded, non-agile crypto
• Lack secure OTA or USB update capabilities
• Still interface with modern systems

For these products, the FDA expects risk-based mitigation strategies, such as:

• Network segmentation
• Decommissioning timelines
• Clear documentation of limitations and ongoing monitoring

Summary: How PQC Readiness Maps to FDA Expectations

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Looking Ahead

You don’t need to implement PQC today - but you do need to plan for change. Regulators want to see that your devices can adapt to the evolving threat landscape, including the eventual shift to quantum-safe standards.

Up Next: Why Preparing for Cryptographic Change Requires More Than a Firmware Update

We’ll explore what crypto-agility really means for medical device architecture - and why secure update mechanisms are just the starting point.

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