Tagged · Section 524B

Section 524B: FDA cybersecurity law for cyber devices

Every article in our archive tagged Section 524B.

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Showing 12 of 45 articles tagged Section 524B · Page 2 of 4

FDA· Jul 30, 2026

Breakthrough Device Designation and Cybersecurity

Breakthrough Device designation speeds FDA interaction but waives no cybersecurity requirement. Here is how Section 524B applies to Breakthrough devices in 2026.

#FDA #Breakthrough Devices #Section 524B

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FDA· Jul 25, 2026

510(k) Cleared, No Postmarket Cybersecurity: Legal?

Cleared under Section 524B but skipping postmarket cybersecurity? Here's what statute, regs, and FDA enforcement actually say - across 510(k), De Novo, PMA, PDP, and HDE.

#FDA #Postmarket #Section 524B

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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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FDA· Jul 21, 2026

FDA Submission Issue Request: Cybersecurity Q-Submission Guide

When to use an FDA Submission Issue Request after a qualifying hold letter, how to frame cybersecurity questions, and why the formal response deadline still applies.

#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 Cyber 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

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 Device Cybersecurity: 2026 Guidance and 7 Threats

FDA AI device cybersecurity in 2026: the February 2026 premarket guidance, PCCPs, the draft AI guidance's 7 threats, and how to cover them under Section 524B.

#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 Submission

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 524B Apply to Legacy Medical Devices?

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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