Tagged · Section 524B

Section 524B articles.

Every article in our archive tagged Section 524B.

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 v7.0.

#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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Penetration Testing· Jun 3, 2026

FDA & AI Pen Testing for Medical Devices

What the FDA's Feb 2026 premarket cybersecurity guidance says (and doesn't say) about AI-run penetration testing, where AI helps, where it fails a 524B.

#Penetration Testing#AI#FDA

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FDA· Jun 2, 2026

FDA Penetration Testing Requirements

What the FDA's Feb 2026 premarket guidance actually requires for medical device penetration testing - what's inside a real pen test, what's separate.

#FDA#Penetration Testing#Section 524B

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FDA· Jun 2, 2026

Letter to File vs New 510(k)

When a cybersecurity change to a cleared device stays as a letter to file in the DHF, and when it forces a new 510(k). Decision framework and examples.

#FDA#510(k)#Section 524B

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FDA· Jun 2, 2026

Special vs Traditional 510(k)

When the FDA accepts a Special 510(k) for cybersecurity changes - BLE, firmware signing, Secure Boot, SBOM swaps - and when it pushes you to Traditional.

#FDA#510(k)#Section 524B

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SBOM & Supply Chain· Jun 1, 2026

SBOM EOS, EOL & LoS for FDA 524B

EOS vs EOL vs Level of Support in your medical device SBOM: what Section 524B requires, how to express it in CycloneDX and SPDX, and how to defend it.

#SBOM#FDA#Section 524B

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FDA· Apr 9, 2026

FDA Cybersecurity Documentation

FDA cybersecurity documentation requirements (2026): SPDF artifacts, Section 524B evidence, SBOM, threat model, testing, and labeling reviewers expect.

#FDA#Documentation#SPDF

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