Tagged · FDA

FDA articles.

Every article in our archive tagged FDA.

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.

#FDA

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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.

#FDA

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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.

#FDA

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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.

#FDA

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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.

#FDA

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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.

#FDA

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