Tagged · Section 524B

Section 524B articles.

Every article in our archive tagged Section 524B.

FDA· Jul 22, 2026

Q-Sub vs Pre-Sub: FDA Cybersecurity Guide

Q-Sub vs Pre-Sub for FDA cybersecurity: what they are, how they differ, and when to use a Pre-Submission to de-risk Section 524B threat models, SBOMs, and pen tests.

#FDA#Pre-Sub#Q-Sub

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Standards· Jul 21, 2026

AAMI SW96 vs TIR57: Did SW96 Replace It?

AAMI SW96 didn't formally replace TIR57, but SW96 is now the FDA-recognized normative standard. Here's what changed and what the FDA expects in 2026.

#AAMI SW96#AAMI TIR57#FDA

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FDA· Jul 21, 2026

FDA SIR Cybersecurity Response: eSTAR Prep Guide

FDA Submission Issue Request (SIR) response strategy for cybersecurity: eSTAR prep checklist, common 524B gaps, and how to answer without restarting review.

#FDA#eSTAR#Cybersecurity

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FDA· Jul 10, 2026

Medical Device Pen Testing: FDA vs EU MDR 2026

Medical device pen testing under FDA vs EU MDR: the 5 FDA report elements, MDR Annex I §17.2/17.4, and how one report serves both submissions.

#FDA#EU MDR#Penetration Testing

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FDA· Jul 10, 2026

Mining FDA Databases for Cybersecurity Precedent

A five-source workflow (510(k), De Novo, PMA, MAUDE, FOIA) for mining FDA cybersecurity precedent by product code before a Section 524B filing.

#FDA#510(k)#De Novo

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Compliance· Jul 10, 2026

FDA PCCP Beyond AI: Cybersecurity, Firmware Uses | Blue Goat

The FDA PCCP guidance isn't AI-only. Use a predetermined change control plan for cybersecurity patches, firmware updates, and SBOM component swaps.

#PCCP#Section 524B#Firmware

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AI & ML· Jun 29, 2026

FDA AI Cybersecurity Threats: 7 Attacks

The FDA's Feb 3, 2026 guidance names 7 AI cyber threats, data poisoning, model inversion, evasion, leakage, overfitting, bias, drift, as 524B obligations.

#AI & ML#FDA#Section 524B

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Compliance· Jun 26, 2026

Does FDA 524B Apply to Auto-Injectors?

FDA Section 524B applies to connected auto-injectors when the device constituent has software and any electronic interface, whether CDER or CDRH leads review.

#Section 524B#Combination Products#Auto-Injector

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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 Section 524B Apply to Legacy

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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