FDA Approval Articles

Expanding Diversity: Beyond Clinical Trials to Human Factors and Label Comprehension

by Scott D. Crawford | Sep 9, 2024

At the end of April 2024, the FDA finalized its rule on Laboratory Developed Tests (LDTs), marking a significant regulatory shift. Labs now face a phased compliance process over four years, adapting to stringent requirements. SoundRocket specializes in human factors and user comprehension studies, essential for FDA submissions. We provide comprehensive support through user and label comprehension studies, simulated use studies, and regulatory guidance. With proven expertise in FDA submission support, SoundRocket ensures your LDTs meet regulatory standards efficiently. Embrace the new regulatory landscape with confidence by partnering with SoundRocket. Visit our services page to learn more.

The FDA 510(k): Bringing a New Genetic Test Directly to Consumers (Part 2)

by Jill Furnival | Oct 5, 2021

So, you’ve developed a genetic test that you’d like to sell directly to the public in the U.S., and you’ve read Part 1 of this two-part series—then you are ready to get some insider tips from a genetic test FDA expert on how to navigate the 510(k) process for your...

The FDA 510(k): Bringing a New Genetic Test Directly to Consumers (Part 1)

by Jill Furnival | Jul 29, 2021

So, you’ve developed a genetic test that you’d like to sell directly to the public in the U.S.—from a regulatory perspective, what do you need to know? To start, some genetic tests require U.S. Food & Drug Administration (FDA) review before being marketed...

How SoundRocket Helped Ancestry.com Achieve FDA Approval (K192947) with Online User Comprehension Studies

by Gina Chiri-Osmond | Apr 23, 2021

When the pandemic began forcing companies to close their physical doors in March 2020, SoundRocket’s Founder and Chief Vision Officer Scott D. Crawford packed up a few belongings and told employees, “Let’s see how this goes. I’m sure we’ll return in a couple of...

FDA Approval

Expanding Diversity: Beyond Clinical Trials to Human Factors and Label Comprehension

The FDA 510(k): Bringing a New Genetic Test Directly to Consumers (Part 2)

The FDA 510(k): Bringing a New Genetic Test Directly to Consumers (Part 1)

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