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In Brief: Home drugs-of-abuse test kits

This article was originally published in The Gray Sheet

Executive Summary

Home drugs-of-abuse test kits: FDA approval of over-the-counter DOA test kits for use in the home likely will require a premarket approval application or product development protocol, FDA says in Sept. 16 revised draft policy on the products. Firms could be allowed to pursue clearance via 510(k) route provided their kits: "do not raise new questions of safety or efficacy" when used at home; "detect the same drug or metabolite" as currently marketed test kits; and demonstrate "the same sensitivity and specificity as the currently available tests which include sequential screening and confirmation provided by the laboratory combination testing algorithms," FDA says. Tests that identify samples as "screened negative" or "indeterminate-need laboratory re-analysis," for example, likely may pursue 510(k) clearance, FDA says, because they do not raise new questions of safety and efficacy. The explanation of premarket requirements modifies an Aug. 25 version of the points-to-consider document ("The Gray Sheet" Sept. 8, p. 6)...
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