FDA hair testing policy
This article was originally published in The Gray Sheet
Executive Summary
Agency formally revokes 1990 compliance policy guide requiring PMA submissions for all radioimmunoassay drugs-of-abuse hair tests in a Jan. 5 Federal Register notice. The tests now require premarket notification, a position consistent with their inclusion in FDA's Dec. 1 DoA testing premarket submission draft guidance designed to clarify the 510(k) process for such products (1"The Gray Sheet" Dec. 8, 2003, p. 12)...