Clinical: FDA Allows Device Exemptions for Drug Testing

For drug testing regulated by most of US federal government, the FDA has exempted certain Class II clinical toxicology systems from 510(k) requirements, as of October 6. The devices are exempted for toxicity tests in 14 substance categories, such as amphetamines, cocaine, cannabinoids, and opiates, including fentanyl. The change will now permit oral fluid testing and hair testing for drug testing in such programs, although the rule does not directly mention those tests specifically.

In the case of the Department of Transportation (DOT) testing, the latest rule sets the stage for changes. The DOT has authorized oral fluid as an alternative method for drug testing but has been unable to implement it due to the FDA’s requirements for 501(k) premarket notification. Now, once two labs are certified by the DHHS for oral fluid testing and the appropriate follow-up steps are taken, the DOT can follow the new rule, According to DISA Global Solutions, around six million drug tests are conducted by the DOT per year.

Oral fluid testing is regarded as more tamper proof than urine testing and can detect drug use more recently. Hair testing can detect drug use farther back in time than urine testing, though an adequate amount of hair for testing may not be available in certain situations.

The federal government is responsible for regulating drug testing in federal programs, including the Substance Abuse and Mental Health Services Administration’s (SAMHSA’s) program for federal workplaces. Current guidelines published by SAMHSA cover urine testing and oral fluid testing.

Sources: DISA (August 7), Federal Register (October 6), National Drug and Alcohol Screening Association (NDASA) (October 6), DrugScreens.com (October 6), ushealthtesting.com (October 8)

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