Tagged · Premarket

Premarket articles.

Every article in our archive tagged Premarket.

FDA· Apr 9, 2026

Medical Device SBOM: FDA Requirements and Submission Guide

Every premarket submission for a cyber device now legally requires a software bill of materials, and missing it can get your submission refused outright. Building a compliant medical device SBOM isn't optional under Section 524B of the FD&C Act, enforced since October 2023. This isn't a recommendati

#FDA#Premarket#SBOM

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FDA· Nov 30, 2025

Navigating the FDA’s 18 Cybersecurity Deliverables for Medical Device Cybersecurity Submissions

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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Podcast· Nov 30, 2025

What Is Required for an FDA Premarket Cyber Submission? | Ep. 47

This episode of The Med Device Cyber Podcast unravels the often-misunderstood requirements for FDA cybersecurity premarket submissions. Hosts Christian Espinosa and Trevor Lynch demystify the 18 essential deliverables that map to the 13 sections of EAR 6.0, emphasizing that docum

#Podcast#FDA#Premarket

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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

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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

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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

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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

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FDA· Feb 25, 2024

SweynTooth in Medical Devices: Lessons for §524B Premarket Submissions

How the SweynTooth family of BLE vulnerabilities affects medical devices, what FDA reviewers expect to see in a §524B submission, and the test evidence that closes the gap.

#FDA#Premarket#Identity & Access

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FDA· Feb 25, 2024

What are Medical Device De Novo Requests?

Discover the ins and outs of a De Novo Request FDA in this informative article.

#FDA#Premarket

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