…refine the GlutenID test materials and the user comprehension study design. FDA User Comprehension Study – A 314-participant study assessing six key comprehension domains, achieving an overall comprehension rate of…
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Introducing a Specialized CRO for FDA 510(k) Study Needs
…for medical device FDA compliance? Common studies include human factors and usability testing, label comprehension, user comprehension, self-selection, and simulated use studies. How can a specialized CRO enhance existing CRO…
Expert advice on designing DTC genetic test reports
…interpretations of genetic information are often complex, unexpected, and highly influenced by their lived experiences. So, how do you design a genetic health risk report to communicate these complex topics…
How SoundRocket Helped Ancestry.com Achieve FDA Approval (K192947) with Online User Comprehension Studies
…knew that people don’t pay close attention to study tasks if left entirely on their own. “The FDA requires a 90% comprehension rate for genetic health risk tests,” says Crawford….
Streamlining FDA Clearance for an Over-the-Counter Fertility Device
…risk. Download a summary of this study. Download Now CLIENT FERTI-LILY SERVICE(S) Self-Selection Study Label Comprehension Study Simulated Use Study 510K CLEARANCE K222969 Download a summary of this study. Download…
Understanding Response Rate vs. Completion Rate: What’s the Difference?
…and Clear: Ensure the survey is easy to follow and doesn’t take too long to complete. Surveys that are overly complex or lengthy often result in low completion rates. Pretest…
Survey Design Best Practices: Creating Usable Surveys
…Research shows that the way questions are displayed influences how respondents interpret them. Research comparing paging (one question per page) and scrolling (multiple questions per page) has shown mixed results….
Direct-to-Consumer Polygenic Risk Scores Move Towards FDA Regulation
…V Leiden Genetic Health Risk Test Download Now Label Comprehension & Human Factors Studies AncestryDNA Saliva Collection Kit Download Now Self Selection Study FERTI-LILY Conception Cup Download Now As health…
The FDA 510(k): Bringing a New Genetic Test Directly to Consumers (Part 1)
…If your genetic test is novel and there is no predicate, your test can pave a new regulatory path. To do this, companies submit a De Novo Classification Request; read…
DEI Surveys & The Religion Question: Dr. J.T. Snipes in Conversation
…of Religion. Patterson’s own research focuses on student experiences and organizational decision-making in higher education, and combines myriad research designs and approaches to explore these topics and communicate key findings….