User Comprehension Articles

Navigating the New FDA LDT Rule with SoundRocket’s Expertise

by Scott D. Crawford | May 17, 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.

Empowering the Home as a Health Care Hub – The Role of User Comprehension Studies

by Scott D. Crawford | Apr 30, 2024

To advance health equity, the FDA has launched the "Home as a Health Care Hub” initiative. This initiative aims to transform the traditional home into a primary setting for health care. This forward-thinking approach recognizes the evolving landscape of medical care,...

Expert advice on designing DTC genetic test reports

by Jill Furnival | Apr 23, 2024

There is little published guidance on how to present genetic or genomic results in an understandable way and at an appropriate reading level for a typical consumer.1 Most of the literature on developing genetic test reports for non-experts (i.e., anyone without...

What is a Label Comprehension Study?

by Jill Furnival | Oct 9, 2022

Label comprehension studies test how well a typical consumer can understand the labeling for an over-the-counter (i.e., non-prescription) drug or medical device. The labeling may include the product box or the instructions for use found inside the package. The idea is...

FDA User Comprehension Studies

by SoundRocket | Jul 22, 2022

What is an FDA user comprehension study? The US Food & Drug Administration (FDA) is responsible for identifying and mitigating consumer risks associated with the products it’s charged to regulate. This includes both prescription products and those sold...

A Website Analysis of the Consumer Genomics Industry Reveals Gaps in Public-facing Information – Part One

by Sophia Bradley | May 5, 2022

When we looked online at genetic tests marketed to consumers, the options were dizzying; after reading the websites we were left with more questions than answers and we wondered—what does this mean for consumers? - Jill Furnival, Genetic Counselor, SoundRocketNew...

Genomic Return of Results Study Underscores Clinical Value, Takeaways for Expanded Implementation

by Jill Furnival | Feb 9, 2022

Biobanks studying genes and human health in large populations are popping up around the globe, but what are researchers to do when they uncover medically important—or potentially lifesaving—results for volunteers who gave their DNA anonymously to science? A research...

Introducing Research Practices to Boost Study Diversity: Inspiration from the Pandemic

by Jill Furnival | Jan 21, 2022

The pandemic (and virtual technology) brought many things into our homes—work, school, doctor’s appointments, the gym, and conferences (to name a few). And while I’m not eager to attend another virtual cocktail party, there have been some at-home adaptations that have...

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...

User Comprehension

Navigating the New FDA LDT Rule with SoundRocket’s Expertise

Empowering the Home as a Health Care Hub – The Role of User Comprehension Studies

Expert advice on designing DTC genetic test reports

What is a Label Comprehension Study?

FDA User Comprehension Studies

A Website Analysis of the Consumer Genomics Industry Reveals Gaps in Public-facing Information – Part One

Genomic Return of Results Study Underscores Clinical Value, Takeaways for Expanded Implementation

Introducing Research Practices to Boost Study Diversity: Inspiration from the Pandemic

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

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