FDA Home-Use Device Design Guidance

01 What the document says

This guidance addresses the risks that arise when a device is used outside a clinical environment by a lay person, and applies to prescription and over-the-counter devices in any class. It is not specific to IVDs, but home-use and over-the-counter diagnostic tests fall squarely within it, and FDA reviewers draw on it when evaluating self-tests and home specimen collection.

The document groups its recommendations under four headings. The user: physical, sensory, and cognitive abilities, literacy and language, and the fact that the operator may be ill, anxious, or a caregiver. The environment: lighting, temperature, humidity, surfaces, interruptions, and the presence of children or pets. The device: usability, robustness, power and alarms where relevant, and how the device fails. Labeling: instructions written and tested for the intended user, including quick reference guides, pictograms, and clear statements of what to do with a result.

It calls for human factors and usability engineering throughout development, with formative studies to refine the design and a summative (validation) study in which representative users perform the critical tasks under realistic conditions. It also discusses post-market considerations such as complaint handling and software updates. For IVDs the practical consequence is that the lay-user study is as much a usability study as a performance study.

02 What it means when you plan a study

• For a self-test, the clinical study operators are untrained lay users, often the patients themselves, recruited to reflect the age, education, and language mix of the intended population; recruitment and consent processes differ from clinic-based studies.
• Sites must be able to observe users performing the test without coaching while still collecting a comparator specimen, which usually means a clinical site with private testing space rather than true in-home testing.
• Labeling must be finalized and tested before the pivotal study, because the labeling is the only training the user receives and any change afterward can call the study into question.
• Result interpretation by the user is itself an endpoint; studies typically record both the user's reading and a trained reader's or instrument reading of the same result, which adds a data collection step at every visit.
• Home-use IVDs that FDA clears or approves are CLIA-waived by category, so the home-use design work and the CLIA waiver evidence overlap; plan the two together.

03 Pathways it applies to

• 510(k) Clinical Studies
• CLIA Waiver Studies
• Dual Submission Studies

Source document: Design Considerations for Devices Intended for Home Use (fda.gov).