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HOME-USE IN VITRO DIAGNOSTICS SHOULD BE TESTED

Executive Summary

HOME-USE IN VITRO DIAGNOSTICS SHOULD BE TESTED by both consumers and professionals in clinical studies, according to an FDA draft "Points to Consider" document on current labeling and premarket clearance requirements for manufacturers of at-home test products. Emphasizing consumer field testing as an important part of a new product submission, FDA says the evaluation should establish "comparable levels of test performance for a particular home-use IVD [in vitro diagnostic] when comparison-tested by both intended users and trained laboratory personnel." Split clinical samples should be tested "by both lay users and trained laboratory personnel with both groups using the home-use IVD," the "points to consider" document states. "Such testing will simultaneously validate the technical performance characteristics of the device and the device's labeling based on user experience." The studies should be double blind. The device center places "considerable importance on the outcome of the consumer field evaluation . . . in assessing the safety and effectiveness of home-use IVDs," the guidance states. As part of the field review, manufacturers should provide study subjects with questionnaires to decide whether consumers can read and understand the labeling. "For example, a questionnaire could be used to determine if the user understands the purpose of the test, the conditions for its use, the test's limitations, the meaning of the results and appropriate followup," FDA suggests. Samples of the questionnaire should be included in a manufacturer's premarket submission. Labeling modifications that have a significant impact on a diagnostic's safety and effectiveness may require FDA clearance before marketing can begin, according to the guidance. Manufacturers also should alert consumers about "significant labeling changes by including special inserts with device packaging which highlight key labeling changes." Product labeling should include sections describing the medical benefits and limitations of the test, suggested followup action, the meaning of false-positive and false-negative test results and possible implications of false results, the agency says. Also, "discussion of specimen collection, preparation, and analysis steps should be enhanced by the use of pictures and illustrations, preferably in color." In reviewing consumer-oriented IVDs, FDA says it will weigh the "probable health benefit(s) to be gained by lay persons" using the devices against "the probable risks associated with their use." "Because home-use IVDs function essentially the same as professional-use IVDs, their performance characteristics can be defined in terms of traditional performance parameters such as sensitivity, specificity, accuracy, and reproducibility of test results," FDA states. "Nevertheless, the performance of the device in the hands of skilled users may not reflect the device's performance in the hands of lay users." Therefore, FDA advises, IVDs for home use "should perform as well as" their professional counterparts: "the ability of the home-use IVD to detect and/or measure a particular analyte of interest (analytical performance) should compare favorably with IVDs used in clinical settings that are intended for the same purpose." The consumer versions "should be designed with a view to ensuring that the device's performance will not be appreciably affected by anticipated variation in user technique," and they should contain a "built-in" user quality control test, the agency suggests.
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