…to take. One such special control is the FDA label comprehension study (or user comprehension study) with a focus on specific knowledge domains. An effectively designed user comprehension study can…
Results for "user comprehension"
What is a Label Comprehension Study?
…target the comprehension needs for your labeling. Experience in survey question wording is invaluable here. The most common pushback that we see from the FDA to a user comprehension study…
Using a Label Comprehension Study for Nonprescription Drug Products
…considerations for label and user comprehension. Read the full guidance document or contact us directly to discuss your user or label comprehension study needs with a genetic test FDA expert….
Consumer Genomics Companies
Specialized FDA user comprehension consultants for consumer genomics User comprehension is critical to authorization – and the future of genetic testing. If genome sequencing is to become commonplace, an understanding…
Navigating the New FDA LDT FinalRule with SoundRocket’s Expertise
…within the Veterans Health Administration and Department of Defense, retain some enforcement discretion. SoundRocket’s Role in LDT Development SoundRocket specializes in human factors, user comprehension, and label comprehension studies critical…
Ancestry closes DNA Health Business only months after obtaining FDA DTC Approval (K192944) with SoundRocket help
…the test report while also designing and implementing a user comprehension study which demonstrated the illusive 90% comprehension in key areas (i.e.: domains) such as test results, test purpose, test…
Expanding Diversity: Beyond Clinical Trials to Human Factors and Label Comprehension
…is also important to have diverse groups of people participate in non-clinical user research. This includes label comprehension, user comprehension, simulated use, self-selection, and other human factors studies. These studies…
FDA Self-Selection Studies
…Genetic Health Risk Test LABEL COMPREHENSION STUDY EU Medical Device Granted US FDA Clearance. USER COMPREHENSION STUDY & ACTUAL USE STUDY Genetic Health Risk Test & Saliva Collection Kit Let…
Co-Pilot
…user understanding and interpret product labeling information. Asses user understanding and retention of key information from provided materials. Determine if users can correctly decide if a product is appropriate for…
FDA Simulated Use Studies
…integrity and participant engagement. Learn More Thorough analysis and detailed reports meeting FDA standards for clear, actionable results. Learn More USER COMPREHENSION STUDY Genetic Health Risk Test LABEL COMPREHENSION STUDY…