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.
Navigating the New FDA LDT Rule with SoundRocket’s Expertise
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