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.

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 Yet, many manufacturers still rely on IT-style cryptography or outdated algorithms that fail to meet device-specific constraints.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.

• 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.