FDA has written controls for a category of home-collected sexually transmitted infection tests into federal regulations. The category combines self-collection at home with testing in a clinical laboratory; it does not describe an instant result obtained entirely at home.
The dates and scope
The order is effective October 9, 2026. It codifies a class II classification applicable on November 15, 2023, following FDA's review of LetsGetChecked's Simple 2 Test.
The category, now in 21 CFR 866.3385, detects nucleic acids from non-viral organisms causing sexually transmitted infections. The devices aid diagnosis and may be intended for prescription or over-the-counter use. That scope does not cover every infection or every home-testing product.
The trip to the laboratory matters
FDA requires the outer box to say that the kit is for home sample collection and that the sample must be shipped to a laboratory within the specified timeframe to receive results. It must also identify intended users and their ages.
Manufacturers must validate specimen integrity during handling and shipping. Clinical studies must include prospective self-collected samples for each claimed specimen type, from people consistent with the intended population, and compare results with an FDA-appropriate comparator.
The collection device must meet the order's FDA authorization requirements, or be cleared with the test using evidence that people can collect samples correctly without a healthcare professional supervising them.
Required warnings and follow-up
The instructions must explain collection, packaging, result interpretation, next steps and technical assistance. The manufacturer's public website must prominently carry required information, including warnings and performance characteristics; over-the-counter tests also need follow-up information.
Required warnings say a negative result does not rule out infection with other pathogens, the system does not replace healthcare visits, and users should not start, stop or change treatment without a healthcare provider's advice.
The order also requires a warning that anyone with recent sexual contact with a person known to have an STI should seek a healthcare provider's treatment and evaluation as soon as possible. Expired kits and failure to follow procedures can produce incorrect results.
The category remains subject to FDA's 510(k) premarket notification requirements. The codification does not announce a new approval for every kit or establish identical performance across products.