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FDA articles.

Every article in our archive in FDA.

FDA· Feb 25, 2024

SweynTooth in Medical Devices: Lessons for §524B Premarket Submissions

How the SweynTooth family of BLE vulnerabilities affects medical devices, what FDA reviewers expect to see in a §524B submission, and the test evidence that closes the gap.

#FDA#Premarket#Identity & Access

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FDA· Feb 25, 2024

What are Medical Device De Novo Requests?

Discover the ins and outs of a De Novo Request FDA in this informative article.

#FDA#Premarket

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FDA· Feb 11, 2024

A Guide to FDA Cybersecurity Documentation

FDA cybersecurity documentation requirements (2025): 524B cyber device rules, SPDF, SBOM, threat modeling, testing, and a premarket submission checklist.

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FDA· Feb 1, 2024

TLS 1.3: Strengthening Medical Device Cybersecurity and FDA Compliance

Discover how TLS 1.3 strengthens medical device cybersecurity, protects patient data, and supports FDA compliance with Blue Goat Cyber.

#FDA#Cryptography

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FDA· Feb 1, 2024

Medical Device Cybersecurity: Creating Effective Password Wordlists for FDA Compliance

Learn how to create powerful and effective password wordlists with our comprehensive guide.

#FDA#Identity & Access

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FDA· Jan 15, 2024

20 Common Medical Device Protocols

This post covers the purposes, security risks, & regulatory guidance for medical device protocols for manufacturers, healthcare providers, & regulatory bodies.

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FDA· Jan 11, 2024

Medical Device Cybersecurity: SBOM & SAST

SBOM + SAST explained: learn how component transparency and static code scanning strengthen medical device cybersecurity, align with FDA guidance, and cut risk.

#FDA#SBOM

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FDA· Jan 9, 2024

Medical Device Threat and Attack Trees

In this post, we explore the differences and similarities between threat trees and attack trees, specifically in the context of medical device FDA clearance and cybersecurity.

#FDA#Threat Modeling

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FDA· Jan 7, 2024

JTAG and UART Vulnerabilities

Updated April 13, 2025 In the rapidly evolving landscape of medical technology, integrating advanced debugging tools like JTAG (Joint Test Action Group) and UART (Universal Asynchronous Receiver-Transmitter) has become a pivotal aspect of medical device design and maintenance. These tools are not ju

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FDA· Jan 6, 2024

FDA Cybersecurity Requirements for Medical Devices (2026)

This post explores the FDA's cybersecurity requirements for medical devices, their importance, and the challenges manufacturers face in complying with them.

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