The Food and Drug Administration (FDA) recently announced a policy change that will expedite the marketing of marijuana testing devices if they’re used for certain purposes.
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.
“FDA’s action decreases regulatory burden on the medical device industry and eliminates private costs and expenditures required to comply with certain Federal regulations,” the notice states.
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.
To that end, the policy change is not intended to help companies market marijuana testing devices designed to analyze THC potency or that include other features that might be beneficial in state-legal markets. The move is exclusively meant to streamline the marketing of drug testing devices for non-federal employment and insurance purposes.
FDA stressed that this change doesn’t impact other regulatory requirements it has for the medical devices industry.
Being exempt from premarket notification requirements “does not mean the device is exempt from any other statutory or regulatory requirements, unless such exemption is explicitly provided by order or regulation,” the agency said.
Rather, “FDA’s determination that premarket notification is unnecessary to provide a reasonable assurance of safety and effectiveness is based, in part, on the assurance of safety and effectiveness that other regulatory controls, such as current good manufacturing practice requirements, provide.”
Photo courtesy of Evan Johnson.
Written by Kyle Jaeger