Tagged · FDA

FDA articles.

Every article in our archive tagged FDA.

FDA· Apr 13, 2025

Guide to Medical Device Cybersecurity Standards (Premarket, Postmarket, & Lifecycle)

Cybersecurity is no longer optional - it’s critical to patient safety and regulatory success. As medical devices increasingly connect to apps, cloud platforms, and hospital networks, manufacturers must follow stringent cybersecurity practices throughout the entire product lifecycle. At Blue Goat Cyber

#FDA#Premarket#Postmarket

Read article

FDA· Apr 12, 2025

FDA Medical Device Submission Costs Explained: 510(k), PMA, and More (2025 Guide)

Navigating the FDA clearance process for medical devices involves more than technical documentation and testing - it involves significant regulatory costs that manufacturers must plan for early. Whether you're submitting a 510(k), Premarket Approval (PMA), or a De Novo request, understanding the latest

#FDA#510(k)#Premarket

Read article

FDA· Apr 12, 2025

How to Navigate the FDA 510(k) and PMA Databases

Updated April 12, 2025 Understanding how to mine FDA databases for insights is a strategic advantage if you're bringing a medical device to market or managing one post-approval. These databases aren’t just regulatory archives. They're treasure troves of competitive intelligence, predicate data, and

#FDA#510(k)#Premarket

Read article

FDA· Nov 17, 2024

V&V and Regression Testing for Medical Device Cybersecurity (FDA §524B)

How verification, validation, and regression testing work together to produce defensible FDA premarket cybersecurity evidence under Section 524B, IEC 62304, and the SPDF.

#FDA

Read article

FDA· Nov 13, 2024

RTOS Cybersecurity for FDA-Regulated Medical Devices

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

#FDA

Read article

FDA· Nov 10, 2024

What is a Modular PMA Submission?

Discover the ins and outs of a Modular PMA Submission, a streamlined approach to gaining FDA clearance for medical devices.

#FDA#Premarket

Read article

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

#FDA

Read article

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.

#FDA

Read article

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.

#FDA

Read article

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.

#FDA

Read article

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

#FDA

Read article

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,

#FDA

Read article

Ready when you are

Get FDA cleared without the cybersecurity headaches.

30-minute strategy session. No cost, no commitment - just answers from people who've shipped 250+ submissions.