User Comprehension Experts are Critical to Success in Meeting Strict Requirements of the FDA
Why Does the FDA Require User Comprehension Studies with OTC and DTC Products?
Unlike medical devices or pharmaceuticals that are managed by healthcare professionals—where a conversation may take place about the meaning of results or test limitations—DTC and over-the-counter (OTC) medical devices bypass the traditional patient-doctor relationship. Genetic Health Risk (GHR) tests are delivered directly to patients. The FDA identifies potential risks to consumers with such DTC tests. They require test manufacturers to conduct “controls” or “special controls” prior to marketing a test for a specific purpose—all designed to reduce risk.
In the GHR protocol, for example, the FDA identifies several risks to the user inherent in these reports, including “incorrect understanding of the device and test system” and “incorrect interpretation of the test results.” To help mitigate these comprehension-related risks, they propose special controls for the test manufacturer 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 ensure that the average consumer understands and interprets the results accurately. Beyond simply meeting FDA requirements, we have found that these efforts also make for a superior product.
The FDA requires a very high bar of 90% comprehension with DTC genetic tests. Key conceptual topics include, but are not limited to:
Detailed Guidelines for Achieving FDA DTC Approval
According to the FDA, the details of what concepts should be included in the GHR report within these domains is left to a “physician and/or genetic counselor that identifies the appropriate general and variant-specific concepts contained within the material tested in the user comprehension study.” SoundRocket will bring this expertise to your study with our in-house Genetic Counselors and several genetics focused collaborators and consultants.
The FDA leaves the specific questions and methods for how to capture comprehension among these domains to the professionals—presumably, to the questionnaire and survey methodologists involved in designing the study. However, they do provide some guidance in how to design and reduce potential bias from various sources. SoundRocket can help build and implement such studies while meeting the FDA’s expectations around bias. Your study with SoundRocket will be fully defensible and will utilize OMB and other federal requirements when submitting to the FDA.
SoundRocket has Specific Expertise in Evaluating Content for Health-Related Reports
Our user comprehension study service is managed in-house by an expert team of genetic counselors, survey methodologists and research/data collection specialists. Our user comprehension studies for regulatory purposes use iterative, multi-method qualitative and quantitative stages to help in optimizing your product and maximizing user comprehension questionnaire validity. We have successfully navigated this path with multiple genetic testing partners—resulting in FDA 510k approval.