Tagged · FDA

FDA articles.

Every article in our archive tagged FDA.

FDA· Jun 25, 2024

Medical Device Authentication & Authorization

The Federal Drug Administration (FDA) wants medical device manufacturers to follow its recommendations for security controls. This “advice” is part of the updated regulations for premarket submissions and postmarket monitoring. The document defines security control categories and how they can improv

#FDA#Identity & Access

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FDA· Apr 29, 2024

FDA Medical Device Cybersecurity Labeling Requirements (2025)

FDA 2025 medical device cybersecurity labeling requirements: interfaces, SBOM, secure configuration, update/patch steps - and mistakes that cause review delays.

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FDA· Apr 21, 2024

The Impact of 524B(b)(2) on Medical Device Cybersecurity

Discover the far-reaching implications of 524B(b)(2) on medical device cybersecurity in this insightful article.

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FDA· Mar 31, 2024

Top BLE Vulnerabilities in Medical Devices (and How to Test for Them in a 510(k))

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

#FDA#510(k)

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FDA· Mar 3, 2024

VxWorks Vulnerabilities in Medical Devices: Triage, SBOM & §524B Evidence

How MedTech teams should identify, triage, and document VxWorks RTOS vulnerabilities (URGENT/11 and beyond) for FDA Section 524B premarket and postmarket submissions.

#FDA#SBOM

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FDA· Mar 2, 2024

Self‑Aware AI in Medical Devices: Risks, Requirements, and FDA Implications

Delve into the fascinating world of self-aware AI as we explore the concept, implications, and potential of artificial intelligence that possesses self-awareness.

#FDA#Risk#AI

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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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