Insights · FDA

FDA articles.

Every article in our archive in FDA.

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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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· Apr 9, 2026

Medical Device SBOM: FDA Requirements Guide (2026)

The four SBOM elements FDA reviewers verify at RTA screening under Section 524B: format (CycloneDX/SPDX), identifiers (PURL/CPE), vuln disposition, update process.

#FDA#Premarket#SBOM

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FDA· Feb 16, 2026

FDA to Scrutinize Medical Device Cybersecurity in 2026

Medical device cybersecurity will face heightened FDA scrutiny in 2026, extending beyond premarket to postmarket performance. Manufacturers must prepare.

#FDA

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FDA· Feb 16, 2026

From Idea to FDA Clearance for MedTech

The biggest MedTech startup mistake isn't the tech. Learn why clarity, FDA planning, quality systems, and cybersecurity determine success. Aligned with the.

#FDA

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FDA· Feb 8, 2026

A New Era for Quality and Safety

How the FDA's QMSR incorporates ISO 13485:2016 and aligns with Section 524B cybersecurity expectations for medical device manufacturers.

#FDA#Risk

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