Many companies that manufacture medical devices are subject to FDA’s premarket notification requirements, which generally involve providing assurances that the products are safe and effective. But under the new guidelines, some cannabinoid testing instruments are exempt from that requirement, meaning they can get to market faster.
However, a device does not qualify for the new exemption if it is “intended for any use other than employment or insurance testing or is intended for Federal drug testing programs,” according to a notice published in the Federal Register last week.
FDA carved out more than 200 exemptions for a wide range of medical devices in the new filing. It took the action to comply with a 2016 law that instructs the agency to identify instruments that no longer require premarket notification and report them in the government publication.
In order for the cannabis testing systems to be eligible for the exemption, companies must include “a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs” such as those used within the Substance Abuse and Mental Health Services Administration or the Department of Transportation.