Tagged · Section 524B

Section 524B articles.

Every article in our archive tagged Section 524B.

Compliance· Jun 23, 2026

Documenting Update Cadence for an FDA

How to document update cadence for an FDA §524B submission: the regular cycle and the out-of-cycle expedited path reviewers expect under §524B(b)(2)(B).

#Section 524B#Premarket#Patching

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Compliance· Jun 23, 2026

Does FDA 524B Apply to Legacy Medical Devices?

FDA Section 524B applies to any new premarket submission for a cyber device, including legacy platforms.

#Section 524B#Legacy Devices#Postmarket

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FDA· Jun 18, 2026

SPDF and IEC 62304 Mapping: FDA Cyber

How SPDF activities map to IEC 62304 software lifecycle processes - the exact crosswalk FDA reviewers expect, where they overlap, and where 62304 falls.

#SPDF#IEC 62304#FDA

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Postmarket· Jun 18, 2026

H-ISAC and Medical Device Threat

The threat intelligence sources medical device manufacturers should monitor to satisfy FDA Section 524B postmarket obligations: H-ISAC, CISA KEV, ICS.

#H-ISAC#Threat Intelligence#CISA KEV

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Compliance· Jun 18, 2026

FDA Section 524B Subsections Explained

A subsection-by-subsection walkthrough of FDA Section 524B for cyber medical devices: what §524B(a), (b)(1), (b)(2), (b)(3), (b)(4), and (c) require.

#Section 524B#FDA#Premarket

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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 Timing: How Recent Must Your

What the FDA's Feb 3, 2026 guidance expects for penetration test recency, version-match, post-change re-testing, and pre-submission remediation, plus.

#Penetration Testing#FDA#Section 524B

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Device Class· Jun 13, 2026

Infusion Pump Cybersecurity: FDA

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

#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

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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