FDA Review of Home-Use Devices

Evaluation of Home-Use performance in the Hands of Lay Users

The manufacturer of a home-use device should first demonstrate that the device produces reliable results in the hands of lay users. Testing to show that the test is accurate is required in the hands of untrained users who would be representative of the population who would actually use the device. The populations studied ideally should include users with a wide variety of socioeconomic, educational, and cultural backgrounds to assess likely real world performance.

FDA recommends that testing of home use devices be conduced under conditions which match as closely as possible real world use. Instructions for use in a study normally are the same as those expected in the final labeling. Special training programs or materials may be provided in a study only if the intention is to make these same materials available with use of the product.

FDA encourages manufacturers to perform direct studies of consumers using the product to determine likely performance. FDA also encourages manufacturers to perform focus testing on new tests to ensure that design features are understood and user friendly and that labeling is optimized for safe and effective use.

Evaluation of Home-Use Benefits and Risks in the Hands of Lay Users

FDA's review of the merit of a home use test takes into account the impact of home access to test results. A major issue in this evaluation is an assessment of whether information can be clearly communicated to lay users and would lead to actions that promote personal or public health and minimize adverse outcomes.

At least two questions are posed in the course of FDA review of a device‘s potential benefits to the home user. The first is whether there is likely to be reasonable labeling developed to allow lay users to obtain a clinical benefit from use of the test in terms of screening, diagnosing or monitoring a particular disease, condition, or risk factor. The second is whether there are likely to be benefits from having the test available to patients at home as opposed to having the test available through usual professional testing sources.

At least two questions are also posed regarding risks of the device in the course of review. The first is what the impact on the user of a false-positive or false-negative result? The second is what are the risks to the user in terms of delay in obtaining professional examination as a result of a false-positive or false-negative results?

Requirements for Home-Use Performance

In the 1988 guidance document FDA outlines three considerations to be addressed in the performance of a home-use device. First the home-use test should perform the same in the hands of lay users as in the hands of professional users. Second the home-use device should be developed with the view to ensuring that the device's performance will not be appreciably affected by variation technique or use environment. Finally, the home-use test should include a simple method by which consumers can determine if the test was performed correctly. Most frequently this involves providing either a user quality control in the kit or a "built in" form of quality control.

Requirements for Home-Use Labeling

Because of the wide variation expected in education and competency of the lay use operator, FDA has developed extensive recommendations which can be followed by manufacturers to develop user-friendly labeling. The 1988 guidance document include information on techniques for evaluating the reading level of a label -- FDA recommends these products be targeted at an 8th grade reading level. The document includes information on how information on test reliability can be reported in a manner understandable to lay users. Finally the agency encourages use of an FDA monograph entitled "Write it Right" which provides manufacturers with further instructions on development of labeling for lay consumer use.

Basic points checked in labeling review are: the need for simplicity through the use of diagrams and pictures to reinforce test, providing information in a question and answer formats, and the identification of a technical assistance number of provide technical support and advice to individuals using a test kit.