The Food and Drug Administration (FDA) has eliminated a federal premarket notification requirement for certain cannabinoid test systems used in federal drug testing programs, a change the agency says could help facilitate the implementation of oral-fluid testing.
The change took effect Tuesday through a final FDA order expanding existing exemptions from the agency’s 510(k) premarket notification requirements for a range of clinical toxicology testing systems.
Until now, cannabinoid test systems intended solely for employment and insurance testing could qualify for an exemption from 510(k) requirements, but devices intended for federal drug testing programs were specifically excluded. The FDA’s new order removes that exclusion.
Under the revised regulation, qualifying cannabinoid test systems intended for employment and insurance testing are exempt from 510(k) premarket notification requirements, including when they are used in federal drug testing programs. The exemption remains subject to other applicable FDA requirements and federal drug-testing standards.
Federal drug testing programs covered by the change include programs administered by the Substance Abuse and Mental Health Services Administration, the Department of Transportation and the U.S. military, according to the FDA.
The FDA said it received comments arguing that eliminating the additional requirement was necessary to help implement oral-fluid testing in federal programs. The agency agreed that the change “may facilitate” the use of oral-fluid testing, while stressing that it does not itself determine whether federal agencies may begin using such testing.
That distinction remains significant. SAMHSA has authorized oral fluid as a specimen type under federal workplace drug-testing guidelines, but its latest certified laboratory information says there are currently no laboratories certified to conduct federal drug and specimen-validity testing using oral-fluid specimens.
Federal drug testing must be performed by facilities certified under SAMHSA’s National Laboratory Certification Program. The FDA said devices exempted under Tuesday’s order remain subject to SAMHSA’s mandatory guidelines when used in federal programs.
The FDA originally proposed expanding the exemptions in May and received comments from about 70 parties. In issuing the final order, the agency concluded that requiring a 510(k) submission is not necessary to provide reasonable assurance of the safety and effectiveness of the covered test systems.
The change also applies to several other categories of drug-testing devices, including tests for amphetamines, cocaine and cocaine metabolites, opiates, benzodiazepines and LSD. For cannabinoid testing specifically, the revised federal regulation took effect October 6.
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