See How Successful FDA Regulatory Studies Are Done Planning a 510(k) submission? Download real study summaries from SoundRocket to see how our research led to FDA clearance.User Comprehension Study AncestryDNA Factor V Leiden Genetic Health Risk TestLabel...
Ann Arbor, MI – February 21, 2025 – SoundRocket, a leader in user comprehension research for regulated medical and diagnostic devices, is proud to announce its role in securing FDA clearance for the GlutenID Celiac Genetic Health Risk (GHR) Test (K241456), developed...
Introduction Questionnaire design is a cornerstone of survey research. It guides the development of questions, structures the survey, and ensures it achieves the intended research objectives. Strong design enhances the validity and reliability of the data collected in...
Navigating FDA regulatory compliance for medical devices is a multifaceted challenge that demands precision, expertise, and seamless collaboration. For medical device regulatory consultants and compliance-focused professionals, partnering with a specialized Contract...
Introducing a Specialized CRO for FDA 510(k) Study Needs Bringing a medical device to market requires navigating complex FDA regulatory pathways for medical devices. These pathways—such as premarket notification (510(k)), premarket approval (PMA), and De Novo...
What is ACNU? ACNU stands for "Additional Condition for Nonprescription Use," a regulatory framework introduced by the U.S. Food and Drug Administration (FDA) to make certain medications available over-the-counter (OTC) while ensuring they are safe and effective for...
Key Areas of Focus for Manufacturers Under the New Guidelines FDA self-selection studies are critical to the regulatory evaluation process, particularly for over-the-counter (OTC) drugs and direct-to-consumer (DTC) The FDA has recently finalized a rule about...
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.