From the LaunchPad

Welcome to The Launchpad, SoundRocket’s blog, where we share our insights and musings on the science of doing science (well), #soundscience.

Navigating the New FDA LDT Rule with SoundRocket’s Expertise

Navigating the New FDA LDT Rule with SoundRocket’s Expertise

by | 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.

read more
FDA Regulatory Oversight is Shifting for LDTs

FDA Regulatory Oversight is Shifting for LDTs

by | 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...

read more