The February guidance
The SPDF era: the full artifact set reviewers expect — threat models, pen-test evidence, labeling, and ISO 14971 linkage.
Free field guide · PDF
Medical Device Cybersecurity2026 Field Guide
The February guidance, the SBOM mandate, and the postmarket duty — with the cybersecurity practice you need.
- Guidance
- Feb 2026
- Federal law
- §524B
- Mandatory
- SBOM
Sourced from verified 2026 publications.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — verified 2026 publications.
The SBOM mandate
Section 524B federal law: SPDX/CycloneDX, CPE/PURL identifiers, VEX, transitive dependencies — and keeping it current under QMSR.
The postmarket duty
The vulnerability management plan: cadence, decision criteria, customer communication, and lifetime security updates.
Sources & scope
- 24x7mag.com, Continuous Compliance for Connected Medical Devices (2026).
- bluegoatcyber.com, Medical Device SBOM: FDA Requirements Guide (2026).
- github.com/qian-qiang/docmcp-knowledge, The SPDF Era Fully Arrives (2026).
- safeguard.sh, Medical Device FDA Supply Chain Cybersecurity 2026.
This guide is market-access intelligence, not regulatory, legal, or engineering advice. FDA cybersecurity expectations, SBOM practice, and vulnerability rules change — professional review is required before business use.
Market Access Strategy Session
Cybersecurity on your 2026 roadmap? Start with the full picture.
A Market Access Strategy Session maps your cybersecurity route — SPDF setup, SBOM generation, and postmarket planning.
Professional review is required before business use.
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