by Scott D. Crawford | Apr 30, 2024 | Regulatory Studies, User Comprehension
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...
by Jill Furnival | Jul 29, 2021 | FDA User Experience Study, Genetic Testing, Regulatory Studies, User Comprehension
So, you’ve developed a genetic test that you’d like to sell directly to the public in the U.S.—from a regulatory perspective, what do you need to know? To start, some genetic tests require U.S. Food & Drug Administration (FDA) review before being marketed...
by SoundRocket | Apr 11, 2024
FDA Genetic Health Risk User Comprehension Guiding you through the complexities of FDA Genetic Health Risk User Comprehension to ensure your product’s clarity and compliance. Schedule a Consult The Challenges of Conducting a User Comprehension Test for 510(k)...
by Scott D. Crawford | May 17, 2024 | Innovative Methodologies, Regulatory Studies, User Comprehension
LDT Regulations from a Human Factors / User Studies Perspective At the end of April 2024, the FDA finalized its rule on Laboratory Developed Tests (LDTs), ending decades of enforcement discretion. This shift mandates comprehensive compliance for LDTs, categorizing...
by Derek Mehraban | Dec 17, 2021 | Climate Surveys, Collaborators, Higher Education
Photo by Michael Barera (CC BY-SA 4.0) Soundrocket conducted an interview with University of Michigan professor Bill Axinn. Bill is a valued client and collaborator, and this post outlines Dr. Axinn’s research, how he first came to find Scott Crawford,...
