Draft Guidance for Premarket Submissions for Kits for Screening Drugs of Abuse To Be Used by the Consumer; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Guidance for Premarket Submissions for Kits for Screening Drugs of Abuse to Be Used By The Consumer.'' This draft guidance addresses screening devices sold over- the-counter for testing drugs of abuse. This type of device is intended for use in the home setting as a screening test for any, or any combination, of the following five substances in urine: Amphetamine/ methamphetamine, cocaine, cannabinoids, opiates, and phencyclidine.