New FDA rule exempts oral fluid and hair drug tests from 510(k) clearance, bringing them into federally regulated testing programs

A U.S. FDA rule that took effect on October 6 exempts certain federally regulated drug testing systems from 510(k) clearance, clearing a regulatory hurdle for oral fluid and hair testing. The ATA said the federal government’s reliance on urine testing leaves loopholes that can be exploited. Oral fluid and hair samples are collected under direct observation and are harder to tamper with, while hair testing has a longer detection window; the exemption applies to 14 categories of testing systems, including those for amphetamines, cannabinoids, cocaine, fentanyl, and opioids.