FDA Final Rule Allows Destruction of Illegal Devices Refused Admission to US

The FDA has finalized a rule allowing it to destroy illegal medical devices valued under $2,500 that have been refused admission into the US as a deterrence against sellers re-shipping items previously refused admission.

In an attempt to circumvent the regulatory system, “Devices that have been refused admission into the United States might be subsequently offered for re-importation by unscrupulous sellers,” the FDA said in its notice in the Federal Register, adding “There is currently little deterrence against sellers shipping illegal devices or re-sending previously refused devices to the United States via international mail or an express courier.”

Examples of the items the FDA has refused admission include those used to diagnose, prevent, or treat COVID-19 such as test kits, respirators, and face masks. Additional 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,” the FDA said.

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