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FDA articles.

Every article in our archive in FDA.

FDA· Dec 4, 2025

Cybersecurity Metrics for FDA Compliance (2026)

Cybersecurity Metrics for FDA Compliance for medical devices: step-by-step practices, FDA-aligned documentation, and pitfalls to avoid in 2026 submissions.

#FDA

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FDA· Nov 30, 2025

FDA’s 18 Cybersecurity Deliverables

Learn how to organize FDA medical device cybersecurity requirements into 18 key deliverables, from threat modeling and SBOMs to testing and labeling.

#FDA#Premarket

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FDA· Nov 5, 2025

What Is a Medical Cyber Device? FDA

FDA cyber-device definition: how software, USB/HDMI/Bluetooth ports, and third-party tools pull a medical device into Section 524B cybersecurity rules.

#Primer

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FDA· Sep 29, 2025

Cybersecurity for Faster FDA Clearance (2026)

Cybersecurity for Faster FDA Approval: a practical 2026 playbook for MedTech leaders, what to prioritize, how the FDA expects it framed, and where teams stumble.

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FDA· Sep 16, 2025

FDA Cybersecurity Rules: More Than Red Tape (2026)

FDA Cybersecurity Rules (Beyond Red Tape) for medical device manufacturers: what the FDA expects in 2026, gaps that trigger deficiencies, and evidence to prepare.

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FDA· Apr 13, 2025

Medical Device Cybersecurity Standards

The 14 medical device cybersecurity standards FDA reviewers expect - ISO 14971, IEC 62304/81001-5-1, AAMI TIR57/TIR97, UL 2900 - mapped to SPDF artifacts.

#FDA#Premarket#Postmarket

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FDA· Apr 12, 2025

FDA Medical Device Submission Costs

Navigating the FDA clearance process for medical devices involves more than technical documentation and testing - it involves significant regulatory.

#FDA#510(k)#Premarket

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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

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FDA· Nov 17, 2024

V&V and Regression Testing for Medical

How verification, validation, and regression testing work together to produce defensible FDA premarket cybersecurity evidence under Section 524B, IEC.

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FDA· Nov 13, 2024

RTOS Cybersecurity for Medical Devices

How to secure real-time operating systems (FreeRTOS, VxWorks, QNX, Zephyr) inside medical devices and evidence the controls in a §524B premarket.

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FDA· Nov 10, 2024

Modular PMA Submission: What MedTech Teams Need to Know (2026)

Modular PMA Submission explained for medical device manufacturers, definition, FDA context, and what teams must document for 2026 submissions.

#FDA#Premarket

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FDA· Oct 23, 2024

Premarket Cybersecurity Insider Tips (2026)

Premarket Cybersecurity Insider Tips: a practical 2026 playbook for MedTech leaders, what to prioritize, how the FDA expects it framed, and where teams stumble.

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