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FDA articles.

Every article in our archive in 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.

Showing 12 of 54 articles in FDA · Page 3 of 5

FDA· May 10, 2026

eSTAR 510(k) Cybersecurity Documentation

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

#FDA #eSTAR #510(k)

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FDA· Apr 10, 2026

How to Respond to an FDA Cybersecurity AI Request

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 Rules

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

510(k) Cybersecurity Requirements Every Maker Must Meet

FDA 510(k) cybersecurity requirements - threat model, SBOM, testing, postmarket plan - scaled across 510(k), De Novo, and PMA pathways under Section 524B.

#FDA #510(k)

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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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FDA· Apr 9, 2026

Medical Device Cybersecurity Risk Analysis

Performing a thorough cybersecurity risk analysis for a medical device isn't optional once your product qualifies under Section 524B of the FD&C Act.

#FDA #Risk

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FDA· Feb 16, 2026

From Idea to FDA Clearance for MedTech

The biggest MedTech startup mistake isn't the tech. See why clarity, FDA planning, quality systems, and cybersecurity decide whether you clear review.

#FDA

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FDA· Feb 8, 2026

What the FDA's QMSR Means for Medical Device Cybersecurity

The QMSR replaced the Quality System Regulation with ISO 13485:2016. Learn what changed, what did not, and how cybersecurity work fits the new structure.

#FDA #Risk

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FDA· Dec 4, 2025

Cybersecurity Metrics for FDA Compliance (2026)

Cybersecurity Metrics for FDA Compliance for medical devices: step-by-step practices, FDA-aligned documentation, and pitfalls to avoid in 2026 submissions.

#FDA

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FDA· Nov 30, 2025

FDA’s 18 Cybersecurity Deliverables

Learn how to organize FDA medical device cybersecurity requirements into 18 key deliverables, from threat modeling and SBOMs to testing and labeling.

#FDA #Premarket

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FDA· Nov 5, 2025

What Is a Medical Cyber Device? FDA Definition

FDA cyber-device definition: how software, USB/HDMI/Bluetooth ports, and third-party tools pull a medical device into Section 524B cybersecurity rules.

#Primer

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FDA· Sep 29, 2025

Section 524B for MedTech Founders: A 2026 Cybersecurity Guide

What FDA Section 524B means for MedTech founders: which devices it covers, the four requirements, and how to budget for cybersecurity before your FDA submission.

#Primer #Risk

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