Substantive Topics 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...

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...

Campus Climate Survey Examples in Higher Education: Case Studies and Outcomes

by SoundRocket | Apr 3, 2024

Ensuring a positive campus experience for all students requires understanding each university’s campus climate – an essential part of guaranteeing a school’s sustainability for faculty and students alike. A campus climate survey is an excellent resource designed to...

Example Campus Climate Survey Questions for Higher Education

by SoundRocket | Mar 28, 2024

Universities looking to achieve diversity objectives often implement campus climate surveys to assess student and faculty life and comfort. A campus climate survey measures how students, faculty, and staff feel supported within a university environment regardless of...

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 Are Campus Climate Surveys & How Do They Benefit Your Institution?

by SoundRocket | May 1, 2023

Campus climate surveys are powerful tools that help colleges and universities gauge campus environment. These surveys provide valuable insight into various aspects of campus life — everything from inclusivity to safety, and play a crucial role in shaping a welcoming...

Why Do You Need Campus Climate Surveys?

by SoundRocket | May 1, 2023

Many universities and colleges conduct regular campus climate surveys. But some may wonder, what insights do they truly bring? Can they actually be used to make higher education institutions a better place? In our experience, when done well, campus climate...

Substantive Topics

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

FDA Regulatory Oversight is Shifting for LDTs

Campus Climate Survey Examples in Higher Education: Case Studies and Outcomes

Example Campus Climate Survey Questions for Higher Education

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

What Are Campus Climate Surveys & How Do They Benefit Your Institution?

Why Do You Need Campus Climate Surveys?

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