The Food and Drug Administration has issued a final rule that, effective July 1, will implement the agency’s authority to destroy medical devices valued at $2,500 or less that have been refused admission into the U.S. Under this rule the FDA must provide the owner or consignee of the device notice and an opportunity to appear and introduce testimony prior to destruction. According to the FDA, this rule extends existing procedures regarding refused drugs to refused medical devices.
The FDA states that it has refused medical devices sent to the U.S. via international mail or express couriers, including illegal devices imported to diagnose, prevent, or treat COVID-19 such as test kits, respirators, and face masks. Examples of other devices that pose significant public health concerns if counterfeit, unapproved, or unauthorized, or otherwise misbranded or adulterated, include contact lenses and blood glucose test strips.
There is currently little deterrence against sellers shipping illegal medical devices or re-sending previously refused devices to the U.S. via international mail or express courier, the FDA states. Devices that have been refused admission might be subsequently offered for reimportation by sellers who attempt to circumvent U.S. import regulatory systems. The FDA asserts that the new rule will better enable it to deter such shipments by providing an administrative mechanism for destroying rejected devices.
Medical devices covered by this rule include instruments, apparatus, implements, machines, contrivances, implants, in vitro reagents, or other similar or related articles, including any component, part, or accessory, intended for use in the diagnosis of a disease or other condition or in the cure, mitigation, treatment, or prevention of a disease or intended to affect the structure or any function of the body, and that does not achieve its primary intended purposes through chemical action within or on the body of man or other animals or by being metabolized.
For more information on this and other FDA issues, please contact FDA consultant Domenic Veneziano at (202) 734-3939 or via email.
This article was originally published in the Sandler, Travis & Rosenberg Trade Report.