Drugs of abuse tests using hair samples outside FDA's scope, Psychemedics argues.
This article was originally published in The Tan Sheet
Executive Summary
DRUGS OF ABUSE HAIR TESTS FALL OUTSIDE FDA PURVIEW, PSYCHEMEDICS argues, because the components of the test systems are not intended to diagnose or treat a disease or condition, the company maintains in a July 6 letter to FDA. "FDA lacks jurisdiction to regulate test systems that detect drugs of abuse in hair because they are not medical devices within the meaning" of the FD&C Act, the Culver City, Calif.-based marketer of the OTC PDT-90 Personal Drug Testing Service asserts.
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