FDA self-selection studies are critical to the regulatory evaluation process, particularly for over-the-counter (OTC) drugs and direct-to-consumer (DTC) medical devices. These studies evaluate whether typical users can accurately choose if a health product is right...
Laboratory Developed Tests (LDTs) have become an essential part of healthcare diagnostics. These specialized tests, developed and processed within CLIA-certified laboratories, offer customized solutions that help close diagnostic gaps left by commercial options. They are particularly important in areas where traditional diagnostics fall short, such as personalized healthcare.
Inclusive clinical trials are essential for ensuring that new treatments and medical interventions benefit all populations, particularly those historically underrepresented in research. By addressing barriers such as non-inclusive screening processes and lack of awareness in LGBTQIA+ communities, the FDA is making strides toward more diverse and representative clinical trial cohorts. This commitment to inclusivity will help create safer, more effective treatments that reflect the needs of all individuals, regardless of gender identity or sexual orientation.
This article will explain the difference between response rate and completion rate, why each matters, and how both can impact the overall data quality of your survey.
Learn about the FDA’s new regulatory changes for Laboratory Developed Tests (LDTs) and how they impact premarket review and authorization. Explore key takeaways and implications for healthcare providers and innovators
Explore how Patient Preference Information (PPI) impacts medical device development and regulatory submissions, with insights from the FDA’s draft guidance and key benefits for manufacturers.
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.
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.
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.