Tagged · 510(k)

510(k) articles.

Every article in our archive tagged 510(k).

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

Read article

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)

Read article

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

Read article

FDA Compliance· Jun 11, 2026

eSTAR v7.0 Cybersecurity for IVDs vs nIVD Submissions

eSTAR v7.0 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

Read article

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

Read article

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

Read article

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)

Read article

FDA· Apr 9, 2026

510(k) Cybersecurity Requirements Every Maker Must Meet

FDA 510(k) cybersecurity requirements - threat model, SBOM, testing, postmarket plan - scaled across 510(k), De Novo, and PMA pathways under Section 524B.

#FDA#510(k)

Read article

FDA· Apr 12, 2025

510(k) Cost: Plan FDA Fees With Confidence

Understand what drives 510(k) cost, plus De Novo and PMA fees: user fees, small business status, testing, cybersecurity work, and consultant spend.

#FDA#510(k)#Premarket

Read article

FDA· Apr 12, 2025

FDA 510(k) & PMA Cybersecurity Guide

Search the FDA 510(k), De Novo, and PMA databases for cybersecurity precedent, product codes, and predicate devices before a Section 524B premarket filing.

#FDA#510(k)#De Novo

Read article

FDA· Mar 31, 2024

BLE Vulnerabilities in Medical Devices

The Bluetooth Low Energy (BLE) vulnerabilities that matter most for FDA-regulated medical devices, and how to evidence them in a §524B premarket.

#FDA#510(k)

Read article

Ready when you are

Get FDA cleared without the cybersecurity headaches.

30-minute strategy session. No cost, no commitment - just answers from people who've shipped 275+ FDA submissions.