Tagged · FDA

FDA articles.

Every article in our archive tagged FDA.

Secure Architecture· Jun 5, 2026

Secure Update Infrastructure for Medical

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

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· May 10, 2026

eSTAR 510(k) Cybersecurity Documentation

Every cybersecurity artifact the FDA expects in an eSTAR 510(k): Section Q mapping, SBOM, threat model, SPDF evidence, and traceability matrix.

#FDA#eSTAR#510(k)

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FDA· Apr 10, 2026

FDA Postmarket Cybersecurity for Cleared

FDA postmarket cybersecurity guidance for cleared medical devices: SBOM monitoring, validated patches, CVD, and 21 CFR Part 806 reporting under Section 524B.

#FDA#Postmarket

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FDA· Apr 10, 2026

How to Respond to an FDA Cybersecurity

Receiving an FDA cybersecurity Additional Information Request (AIR) doesn't mean your submission is dead. Aligned with the FDA's Feb 3, 2026 premarket.

#FDA#AI

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FDA· Apr 10, 2026

ISO 27001 & SOC 2 vs FDA Medical Device

Why ISO 27001 and SOC 2 don't satisfy FDA medical device cybersecurity: the gaps in Section 524B evidence and what reviewers require instead.

#FDA#Standards

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FDA· Apr 9, 2026

FDA Cybersecurity Deficiencies Triggers

Understanding what causes the FDA to issue a cybersecurity deficiency for medical devices starts with one uncomfortable truth: most deficiencies have.

#FDA

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