Insights · FDA

FDA articles.

Every article in our archive in FDA.

FDA· Oct 22, 2024

NFC & RFID Security in Medical Devices

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

#FDA

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FDA· Oct 20, 2024

FDA QSR & Cybersecurity: Medical Device Compliance Guide (2026)

Explore FDA's Quality System Regulation (QSR) for medical device cybersecurity: key guidelines, compliance strategies, and best practices for MedTech.

#FDA

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FDA· Sep 18, 2024

FDA Cybersecurity & Interoperability

FDA medical device cybersecurity standards and interoperability considerations: what the Feb 2026 guidance requires for connected device submissions.

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FDA· Jun 25, 2024

FDA Authentication and Authorization Controls (2026)

FDA Authentication & Authorization Controls for medical device manufacturers: what the FDA expects in 2026, gaps that trigger deficiencies, and evidence to prepare.

#FDA#Identity & Access

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FDA· Apr 29, 2024

FDA Medical Device Cybersecurity Labeling

FDA 2026 medical device cybersecurity labeling requirements: interfaces, SBOM, secure configuration, update/patch steps - and mistakes that cause review.

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FDA· Apr 21, 2024

Section 524B(b)(2): Medical Device

Section 524B(b)(2) makes cybersecurity statutory for FDA cyber devices: SPDF design controls, vulnerability management, and a working patch/update mechanism.

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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)

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FDA· Mar 3, 2024

VxWorks Vulnerabilities in Medical Devices

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

#FDA#SBOM

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FDA· Feb 25, 2024

CBER: What MedTech Teams Need to Know About FDA Biologics (2026)

CBER (Center for Biologics Evaluation and Research) explained for medical device manufacturers, definition, FDA context, and what teams must document for 2026 submissions.

#Primer

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FDA· Feb 25, 2024

What is CDRH? FDA's Device Center Explained

The essential role of the Center for Devices and Radiological Health (CDRH) in ensuring the safety, effectiveness, and cybersecurity of medical devices.

#Primer

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FDA· Feb 25, 2024

SweynTooth BLE Vulnerability in Medical Devices

SweynTooth BLE Vulnerability in medical devices: attack scenarios, patient-safety impact, and mitigations FDA reviewers expect in 2026 submissions.

#FDA#Premarket#Identity & Access

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FDA· Feb 25, 2024

What are Medical Device De Novo Requests?

De Novo Requests establish classifications for novel medical devices without predicates. Blue Goat Cyber helps manufacturers navigate this FDA pathway.

#FDA#Premarket

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