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FDA Compliance articles.

Every article in our archive in FDA Compliance.

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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FDA Compliance· Jun 11, 2026

Interoperability Labeling for Devices

What the FDA's Feb 2026 guidance expects in interoperability labeling for connected medical devices, and where each element sits in the eSTAR package.

#Interoperability#Labeling#HL7 FHIR

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FDA Compliance· Jun 11, 2026

MDS2 and HSCC Disclosure for Medical

What the MDS2 / HSCC Manufacturer Disclosure Statement for Medical Device Security covers, what the FDA's Feb 2026 guidance expects in the disclosure.

#MDS2#HSCC#Labeling

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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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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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