Tagged · 510(k)

510(k) cybersecurity requirements

Every article in our archive tagged 510(k).

What you need to know

Most connected devices reach the U.S. market through a 510(k), and since Section 524B took effect, a 510(k) for a cyber device must include cybersecurity evidence. Claiming substantial equivalence to a predicate does not exempt a device: if the predicate was cleared without modern cybersecurity documentation, the new submission still has to provide it.

The articles below cover what reviewers expect in a 510(k), how Traditional, Special and Abbreviated submissions differ, how to use the FDA databases to find precedent, and when a software or security change can go in a letter to file instead of a new 510(k).

Start here

Looking for a quick answer instead? The FDA medical device cybersecurity FAQ covers Section 524B scope, SBOMs, threat models, CR515 and GMLP, deficiencies, and postmarket duties.

Showing 10 of 10 articles tagged 510(k)

Compliance· Sep 26, 2026

FDA Cybersecurity Deficiency Response Timeline Guide

FDA cybersecurity deficiency response timeline: the 180-day clock, how holds work for 510(k), De Novo, and PMA, and a week-by-week plan to answer on time.

#Deficiency Letter #Additional Information #510(k)

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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 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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FDA Compliance· Jun 11, 2026

eSTAR v7.1 Cybersecurity for IVDs vs nIVD Submissions

eSTAR v7.1 cybersecurity attachments 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· Jun 2, 2026

Letter to File vs New 510(k)

When a cybersecurity change to a cleared device stays as a letter to file in the DHF, and when it forces a new 510(k). Decision framework and examples.

#FDA #510(k)#Section 524B

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FDA· Jun 2, 2026

Special vs Traditional 510(k)

When the FDA accepts a Special 510(k) for cybersecurity changes - BLE, firmware signing, Secure Boot, SBOM swaps - and when it pushes you to Traditional.

#FDA #510(k)#Section 524B

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FDA· May 10, 2026

eSTAR 510(k) Cybersecurity Documentation

Every cybersecurity artifact the FDA expects in an eSTAR 510(k): Cybersecurity attachment mapping, SBOM, threat model, SPDF evidence, and traceability matrix.

#FDA #eSTAR #510(k)

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FDA· Apr 9, 2026