Insights · FDA

FDA articles.

Every article in our archive in FDA.

FDA· Oct 23, 2024

Medical Device Cybersecurity Insights

Updated October 26, 2024 As the medical device industry continues to innovate, cybersecurity has become critical to ensuring new products' safety, effectiveness, and market success. With the FDA's evolving requirements, manufacturers must adopt a proactive approach to cybersecurity throughout the pr

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FDA· Oct 22, 2024

NFC & RFID Security in Medical Devices: A §524B-Aligned Guide

The complete guide to NFC and RFID cybersecurity for FDA-regulated medical devices - vulnerabilities, threat modeling, test evidence, and §524B / SPDF documentation.

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FDA· Oct 20, 2024

What are FDA Deficiency Letters for Medical Devices?

Discover everything you need to know about FDA deficiency letters for medical devices in this comprehensive article.

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FDA· Oct 20, 2024

FDA’s Quality System Regulation (QSR): Ensuring Medical Device Cybersecurity Compliance

Explore FDA’s Quality System Regulation (QSR) for medical device cybersecurity, including key guidelines, compliance strategies, and best practices for safety.

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FDA· Oct 20, 2024

FDA Medical Device Classifications

Updated November 16, 2024 Medical devices are integral to healthcare, ranging from simple tools like bandages to complex machines like pacemakers. The U.S. Food and Drug Administration (FDA) classifies these devices into three categories based on their risk level and intended use. This classificatio

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FDA· Sep 18, 2024

Medical Device Cybersecurity Interoperability Considerations

Updated October 26, 2024 The Federal Drug Administration (FDA) created medical device cybersecurity standards with its guidance most recently updated on February 3, 2026. The agency delivered explicit requirements and additional best practices within these new rules. One area of concentration was interoperability. So,

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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

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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.

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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.

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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.

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