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FDA articles.

Every article in our archive tagged FDA.

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.

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Showing 12 of 81 articles tagged FDA · Page 3 of 7

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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Threat Modeling· Jun 12, 2026

Data Flow Diagrams for Medical Device

What a DFD is, the five DFD elements, and how data flow diagrams feed STRIDE threat modeling and the FDA's Security Architecture Views in a 2026.

#DFD #Threat Modeling #STRIDE

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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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FDA Compliance· Jun 11, 2026

eSTAR v7.0 Cybersecurity for IVDs vs nIVD Submissions

eSTAR v7.0 cybersecurity slots are identical for IVD and nIVD submissions, but the content reviewers expect is not. Here's how to fill each section correctly.

#IVD #eSTAR #FDA

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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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Penetration Testing· Jun 11, 2026

Penetration Test Case Design for Medical

How to design penetration test cases from a medical device threat model, the methodology that bridges STRIDE-style threats and concrete bench test.

#Penetration Testing #Threat Modeling #eSTAR

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FDA Compliance· Jun 11, 2026

Unresolved Anomalies in FDA Cybersecurity

What the FDA's Feb 2026 guidance expects in the unresolved cybersecurity anomalies assessment, how to document residual risk, and the deficiency pattern.

#FDA #Residual Risk #Deficiency Response

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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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