Meeting FDA Expectations for Cryptographic Security in Medical Devices

The FDA’s latest cybersecurity guidance sets a clear expectation: cryptography is a cornerstone of medical device security.
This whitepaper provides a deep dive into how medical device manufacturers (MDMs) can meet FDA expectations for cryptographic design and implementation — covering key principles such as authenticity, integrity, and confidentiality.
It explores the most common mistakes in cryptographic design, clarifies how FDA expectations align with NIST standards like FIPS 140-3 and SP 800-131A, and outlines practical best practices for developing compliant and secure medical devices.

A case study highlights how Medcrypt’s Guardian Platform helps manufacturers streamline cryptographic implementation and achieve FDA-ready compliance faster.

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Cryptography isn’t just about encryption — it’s about establishing trust.FDA guidance (Premarket Cybersecurity, September 2023) now explicitly requires that devices demonstrate secure cryptographic capabilities, including key generation, management, certificate provisioning, and lifecycle security controls.Yet, many manufacturers still rely on IT-style cryptography or outdated algorithms that fail to meet device-specific constraints.This paper helps manufacturers close that gap by explaining how to translate regulatory language into practical, auditable design decisions.

• Product security and engineering teams designing connected or cloud-enabled medical devices
• Regulatory and quality professionals preparing cybersecurity documentation for FDA submissions
• Executive leaders and program managers responsible for FDA readiness and compliance strategy
• R&D architects and cryptography specialists developing secure communication and key management infrastructures

• FDA expects manufacturers to design, implement, and document cryptography as part of their SPDF.
• Using “off-the-shelf” IT cryptography is often insufficient — devices require domain-specific implementation.
• Common pitfalls include key reuse, weak storage, and lack of lifecycle management.
• Cryptographic functions should map directly to FDA’s three pillars: authenticity, integrity, and confidentiality.
• Medcrypt’s Guardian Platform enables scalable, compliant cryptographic identity management and mutual authentication for connected medical devices.

1. Introduction
   
   1. Why cryptography is a regulatory and patient safety imperative
   2. Differences between IT cryptography and medical device cryptography
   3. How device constraints (resources, connectivity, lifecycle) complicate implementation
2. FDA Security Recommendations
   
   1. Overview of FDA cybersecurity expectations for authenticity, integrity, and confidentiality
   2. How FDA leverages NIST expertise for algorithm validation
   3. FDA focus on cryptographic implementation — not just algorithm selection
   4. Mapping cryptographic functions to FDA’s Secure Product Development Framework (SPDF)
3. Cryptography Gone Wrong — Common Pitfalls
   
   1. Shared keys and reused credentials across devices
   2. Improper key lifecycle management or insecure storage
   3. Failure to account for key rotation, revocation, and re-provisioning
   4. Weak or deprecated algorithms and “rolled your own” cryptography
   5. Using IT-based crypto approaches unsuited for medical devices
4. Cryptography Best Practices in Medical Devices
   
   1. Device-specific implementation principles
   2. Generating unique per-device and per-function keys
   3. Secure firmware signing, trusted boot, and anti-replay mechanisms
      
   4. Mutual authentication using TLS 1.3 and modern PKI models
   5. Hardware-based security and use of FIPS 140-3–validated HSMs
5. Case Study: Simplifying Secure Device Development with Medcrypt’s Guardian Platform
   
   1. Overview of Medcrypt’s Guardian architecture and scalability
   2. How Guardian supports east-west and north-south communication security
   3. Real-world example: securing an orthopedic system suite using unique Roots of Trust
   4. How Guardian accelerates FDA submission readiness
6. Appendix A: Translating FDA Requirements to Cryptographic Implementation
   
   1. Mapped requirements from FDA Appendix 1 (Authentication, Integrity, Confidentiality)
   2. Recommended algorithm families and lifecycle controls
   3. Design recommendations for secure communication paths and cryptographic validation
7. Appendix B: Cryptography Use Cases & Best Practices
   
   1. Device cryptography principles (key uniqueness, revocation, secure boot)
   2. Certificate management and renewal strategies
   3. PKI governance and HSM best practices for certificate authorities and responders
8. Resources
   
   1. FDA Premarket Cybersecurity Guidance (2023)
   2. NIST FIPS 140-3, SP 800-131A, ISO/IEC 19790, ISO/IEC 24759
   3. Artech House Medical Device Cybersecurity for Engineers and Manufacturers