Tagged · FDA

FDA articles.

Every article in our archive tagged FDA.

FDA· Sep 17, 2026

Home Use vs Hospital Device Cybersecurity Requirements

Home use vs hospital device cybersecurity: which controls the HDO environment provides, which the device must carry itself, and how the FDA reviews each case.

#FDA#Intended Use#Home Use Devices

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FDA· Jul 30, 2026

Indications for Use, Predicates, and Cybersecurity Scope

How your Indications for Use statement and predicate choice change the cybersecurity scope of a 510(k): use environment, harm ceiling, pen test scope, and Special 510(k) eligibility.

#FDA#510(k)#Indications for Use

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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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Compliance· Jul 23, 2026

Premarket Cybersecurity in Your QMS: ISO 13485 & QMSR

Where FDA premarket cybersecurity artifacts live in an ISO 13485 / QMSR quality system: DHF, risk management file, DMR, and postmarket - clause-by-clause map.

#QMSR#ISO 13485#FDA

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FDA· Jul 23, 2026

Types of 510(k): Traditional, Special, Abbreviated

The three types of 510(k) - Traditional, Special, and Abbreviated - explained side by side, with the cybersecurity implications of each under Section 524B.

#FDA#510(k)#Traditional 510(k)

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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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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 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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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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