Guidance for Premarket Submissions for Kits for Screening Drugs of Abuse to Be211 Used by the Consumer. Guidance for Industry

摘要

This guidance document represents the Food and Drug Administration's (FDAs)211u001ecurrent thinking on Premarket Submissions for Drugs of Abuse Screening Kits sold 211u001eover the counter (OTC). It does not create any rights for any person and does not 211u001eoperate to bind FDA or the public. An alternative approach may be used if such 211u001eapproach satisfies the requirements of the applicable statute, regulation, or 211u001eboth. FDA has developed a proposal for regulating OTC test sample collection 211u001esystems for drugs of abuse. That proposal is outline in a Federal Register Notice 211u001e(Docket No. 97N-0135). The systems addressed are those where a urine sample is 211u001ecollected at home, mailed to certified laboratories, and tested and interpreted 211u001eby professional laboratory personnel using FDA cleared products.