Regulatory Studies Archives

Navigating the New FDA LDT FinalRule 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...

FDA Regulatory Oversight is Shifting for LDTs

by Jill Furnival | Apr 10, 2024

Laboratory-developed tests, or LDTs, are in vitro diagnostic (IVD) tests designed and conducted in a single laboratory and ordered by a licensed practitioner. By definition, LDTs are not commercially manufactured, marketed, or sold in volume. They are essential to...

Direct-to-Consumer Polygenic Risk Scores Move Towards FDA Regulation

by Jill Furnival | Mar 10, 2024

In medicine, we have been discussing the promise of polygenic risk scores for some time now. Polygenic risk scores determine whether a person's risk for a common condition, like coronary artery disease or depression, is higher or lower than others. The hope is to use...

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...

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...

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...

Regulatory Studies

Navigating the New FDA LDT FinalRule 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

FDA Regulatory Oversight is Shifting for LDTs

Direct-to-Consumer Polygenic Risk Scores Move Towards FDA Regulation

What is a Label Comprehension Study?

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

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)

What We Do

How We Do it

About Us

Get our latest social science insights delivered straight to your email