Tagged · Section 524B

Section 524B: FDA cybersecurity law for cyber devices

Every article in our archive tagged Section 524B.

Looking for a quick answer instead? The FDA medical device cybersecurity FAQ covers Section 524B scope, SBOMs, threat models, CR515 and GMLP, deficiencies, and postmarket duties.

Showing 12 of 43 articles tagged Section 524B · Page 3 of 4

Compliance· Jun 18, 2026

CAPA and Medical Device Cybersecurity

How to run CAPA for medical device cybersecurity findings: when a vulnerability or FDA deficiency triggers a CAPA, and what evidence closes it out.

#CAPA #QMSR #FDA

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Compliance· Jun 18, 2026

HHS 405(d) HICP Practice #9 for 524B

How HHS 405(d) and the Health Industry Cybersecurity Practices (HICP) Medical Device Security practice maps to FDA Section 524B artifacts, and how.

#HHS 405(d)#HICP #FDA

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Pen Testing· Jun 15, 2026

FDA Pen Test Requirements: Timing, Scope and Recency

What an FDA pen test must include and how recent it must be under the Feb 3, 2026 guidance: version match, re-testing after changes, and fixing findings before you file.

#Penetration Testing #FDA #Section 524B

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Device Class· Jun 13, 2026

Infusion Pump Cybersecurity: FDA Expectations

What the FDA expects from infusion pump cybersecurity submissions in 2026: threat model focus areas, Section 524B evidence, and the deficiencies reviewers cite.

#Infusion Pumps #FDA #Section 524B

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Postmarket· Jun 13, 2026

Medical Device Incident Response Plan

What the FDA's Feb 3, 2026 final premarket cybersecurity guidance expects from a medical device incident response plan, who owns it, and the documents.

#Incident Response #FDA #Section 524B

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Compliance· Jun 12, 2026

IEC 62304 Classes vs FDA Device Classes

IEC 62304 software safety classes (A/B/C) and FDA device classes (I/II/III) are not equivalent.

#IEC 62304 #FDA #Section 524B

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Testing· Jun 11, 2026

Docker Containers in Medical Devices: FDA Testing

Where containers appear in medical devices, the testing the FDA expects under the Feb 3, 2026 guidance, and how container evidence maps to eSTAR v7.1.

#Containers #Docker #SBOM

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SBOM & Supply Chain· Jun 11, 2026

SBOM for Third-Party Chip Firmware

When a chip vendor's SBOM is enough, when it isn't, and what changes the moment a MedTech team modifies modem, radio, or SoC firmware in the device.

#SBOM #Firmware #Section 524B

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FDA Compliance· Jun 11, 2026

Patch and Update Mechanism Testing

Section 524B(b)(1) makes patchability statutory. What the FDA's Feb 2026 guidance expects in the patch and update mechanism test evidence, the test cases.

#FDA #Section 524B #Patchability

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Penetration Testing· Jun 11, 2026

DAST vs Penetration Testing for FDA Submissions

DAST is a subset of FDA-required penetration testing. What the Feb 2026 guidance expects in eSTAR Slot 7, and why a Burp scan alone will fail review.

#Penetration Testing #DAST #FDA

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Secure Architecture· Jun 5, 2026

Secure Update Infrastructure for Medical Devices

How to design, isolate, and defend the update channel for connected medical devices - signed manifests, dual-bank A/B, rollback protection, HSM-backed.

#FDA #Section 524B #Secure Updates

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FDA Compliance· Jun 4, 2026

Does Device Class Decide FDA Cybersecurity Scope?

Class I, II, III doesn't decide your FDA cybersecurity burden. Section 524B's cyber-device test and whether you file a premarket submission do.

#FDA #Section 524B #Device Classification

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