FDA Releases Draft Guidance for Over-the-Counter Drug Screening Devices

Summary

The Food and Drug Administration (FDA) has released a draft guidance document titled 'Guidance for Premarket Submissions for Kits for Screening Drugs of Abuse to Be Used By The Consumer.' This document outlines the requirements for screening devices sold over-the-counter for testing drugs of abuse, which are intended for use in the home setting to screen for various substances, including amphetamine, cocaine, and opiates.