FDA User Comprehension Studies

What is an FDA user comprehension study?

The US Food & Drug Administration (FDA) is responsible for identifying and mitigating consumer risks associated with the products it’s charged to regulate. This includes both prescription products and those sold over-the-counter (OTC) directly to consumers (DTC). Prior to promoting a DTC test for a specific use, the FDA requires test manufacturers to submit a 510(k) or Premarket Notification. As part of this submission, they must comply with controls or special controls (i.e. specific measures or requirements outlined in the CFR), which aim to reduce risk. An FDA user comprehension study is one such special control required to obtain premarket authorization for DTC in vitro diagnostic products, such as genetic tests. 

User comprehension studies ensure people who have DTC genetic tests for medical purposes, such as genetic health risk (GHR) or pharmacogenetics tests, can understand the meaning of their results on their own (i.e.: without a healthcare provider) based on the materials provided. 

Here’s five key things to know about user comprehension studies for FDA premarket submissions:

1. The goal is to evaluate a representative sample of the contents that are generated as the report, which can include a public facing website with test details, a pre-purchase page, a frequently asked questions page, technical details, as well as the test report itself.
2. The manufacturer must include an education module to define terms used or concepts addressed in the report. 
3. Studies must be conducted on naive users who have no prior experience with the product or test. 
4. Studies must include enough cases and diversity in age, race/ethnicity, and education level
5. The study design must include both pre- and post- test comprehension studies 

What specifically does a FDA user comprehension study test for?

The GHR authorization, for example, specifies that genetic test reports must be evaluated to ensure they achieve 90% comprehension, on items in the following five domains (topics):

• Test limitations
• Test purpose
• Appropriate actions (next steps)
• Other factors that may have an impact on the test results
• Test results

Bonus

User comprehension studies will make your product better, both easier to understand and to act on. We have seen it time and time again.  

Consult survey experts

Conducting comprehension studies that meet the FDA’s high bar of comprehension requires expertise in study design, objectives, population makeup, questionnaire development, statistical considerations and data analysis. We suggest enlisting help from experts, like us, to make your project successful. 

If you need to perform user comprehension studies for your DTC genetic test product, let’s talk!