What changes in the quote when we add a consumer test?
A test adds a physical product, specimen workflow, result claim, and possibly a laboratory or clinician relationship. FDA says DTC tests follow different pathways based on purpose and risk, so update the product description and ask the broker to review the test separately from the app.
Describe who collects the specimen, who analyzes it, what the result says, and whether a clinician interprets it. Include the test’s intended use and the vendors that handle samples or results.2,1
Ask which forms address allegations about the app, test performance, instructions, and physical kit. Request the exact triggers and exclusions for each.2,6
Read the Consumer Health and Wellness Insurance Buying Guide
Sources and Further Reading for Consumer Health and Wellness
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