…pros with your FDA user comprehension study. Turn to survey experts (like us) who are familiar with user or label comprehension studies for regulatory purposes, as we know what the…
Results for "user comprehension"
FDA Self-Selection Studies
…to precisely meet your research requirements with the utmost professionalism. We have deep knowledge to design rigorous, effective user comprehension studies. Work closely with our team for tailored solutions and…
Helix enters DTC game with broad whole exome sequencing platform
…the company, and comprehension of test materials through user comprehension studies. The Helix Laboratory Platform The Helix Laboratory Platform (HLP) was submitted as a data generation tool only, with no clinical or interpretation…
Research Wonder: DNA with a bow on it, a gift that may (unexpectedly) ‘keep on giving’
… The FDA oversees DTC GHR products. An important part of the FDA authorization process is user comprehension. They require test manufacturers to conduct user comprehension studies—demonstrating that the…
FDA Simulated Use Studies
…user risks. Test user interactions and ensure compliance with FDA usability standards. We’ve developed a tested and proven approach called Co-Pilot (Comprehension Pilot) for FDA simulated use studies. Our team…
The FDA 510(k): Bringing a New Genetic Test Directly to Consumers (Part 1)
…materials) can be understood by a consumer without the involvement of a healthcare provider. This is done by conducting a user comprehension study. Now that you know some 510(k) basics,…
FDA Risk Analysis for Your Medical Devices: What You Need to Know Now
FDA Risk Analysis, including Use-Related Risk Analysis (URRA), is no longer optional—it’s essential for medical device compliance. This guide explains URRA, why it’s vital for FDA submissions, and how to…
Streamlining FDA Clearance for an Over-the-Counter Fertility Device
…FERTI-LILY to conduct three consumer comprehension studies: a self-selection study, a label comprehension study, and a simulated use study. These studies evaluate whether typical users can correctly self-select the product…
Decoding FDA DTC Policy: Part 1 – Pharmacogenetics Are Here!
…located in Ann Arbor, Michigan. He is trained as a Survey Methodologist (University of Michigan, 2000) and has been involved in user comprehension research (among other fields) for government, academic…
Navigating the FDA’s Final Rule on ACNU for Nonprescription Drugs
…how our research led to FDA clearance. User Comprehension Study AncestryDNA Factor V Leiden Genetic Health Risk Test Download Now Label Comprehension & Human Factors Studies AncestryDNA Saliva Collection Kit…