By Diagnostics World Staff
November 10, 2026 | Many in vitro diagnostic (IVD) and over-the-counter test makers became interested in wellness claims after the FDA’s dispute with Whoop. They hoped to avoid standard medical device requirements. According to Dan Simpson, director of regulatory affairs at DCN Dx, that path is narrower than many assume.
The FDA updated its general wellness guidance in January 2026. Simpson says the update opened the door wider for some software applications than for IVDs. The agency does not consider biomarkers detected by lateral flow assays, such as insulin and cortisol, to be purely wellness measures, because they carry medical connotations and could be misused. Even implying a disease state is a concern. Glucose and insulin, for example, are commonly associated with diabetes.
“If you mention a disease state, you are at risk of becoming a medical device,” Simpson says.
He advises IVD companies considering a wellness indication to consult the FDA first. Options include an email classification inquiry, a pre-submission meeting under the Q-Submission program, or a 513(g) request. Each has trade-offs. Companies that pursue the regulated path generally go through 510(k), De Novo, or premarket approval. Simpson says the harder route may yield a better product but costs more.
Emily Friedland, a DCN Dx vice president, notes that consumers rarely check a product’s regulatory status. As one example, she cites nursing mothers using uncleared tests to check breast milk for alcohol.
Read the full story at Integrative Practitioner.