US: Importing COVID-19 Diagnostic Test Kits

AUTHOR: Reynaldo Roman | Senior Director, Regulatory Compliance

COVID-19 diagnostic test kits and other in vitro diagnostic devices (IVDs) are FDA-regulated products that require FDA and Customs and Border Protection (CBP) clearance when imported into the US.

The FDA regulates imported medical devices and IVDs. Generally, imported devices must have FDA marketing approval or must be authorized under an approved Investigational Device Exemption (IDE), or other FDA-approved application or exemption. Devices that cannot meet these criteria are often refused entry by the FDA.

To facilitate access to COVID-19 diagnostic test kits, the FDA has issued Emergency Use Authorization (EUA) and enforcement discretion policies that allow certain COVID-19 IVDs to be imported and marketed in the US. These FDA policies support trade by lifting some the restrictions that normally apply to the import of medical devices.

A full list of Emergency Use Authorizations and enforcement discretion policy guidance documents currently in place are available on the FDA’s website.

When importing COVID-19 diagnostic test kits or devices, importers must provide product details and specify which FDA authorizations apply to the devices in order to obtain a Customs and FDA release. Failure to declare the imported devices correctly may result in clearance delays or entry refusal by the agencies.

Questions related to the import of COVID-19 test kits can be sent to tradecompliance@marken.com.

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