FDA OTC drugs-of-abuse testing interim policy allows kits on market without preclearance.
This article was originally published in The Tan Sheet
Executive Summary
FDA OTC DRUG TESTING INTERIM POLICY ALLOWS HOME DRUG TESTS for drugs of abuse to go on the market without premarket review. The one-page interim agency policy, issued Oct. 3, spells out FDA's plan to soften its regulatory stance on home-use drug tests while it develops a final agency policy defining what, if any, premarket requirements should be imposed on the tests. Prior to the interim policy, OTC drugs-of-abuse tests were deemed Class III devices, subject to premarket approval application requirements.