Liquid-Filled Thermometers & Pyrometers for Direct Reading (Not Combined with Other Instruments)

Clinical thermometers are classified as Class II medical devices by FDA. Foreign manufacturers must be registered with FDA, and the devices must comply with applicable performance standards and labeling requirements. Shipments may be subject to FDA examination at the port of entry; importers should ensure the foreign establishment is listed in FDA's device registration database prior to shipment. Consult a licensed customs broker or regulatory affairs specialist for admissibility guidance.

Mercury-containing thermometers face significant restrictions. EPA regulations under the Toxic Substances Control Act (TSCA) prohibit the manufacture and sale of mercury fever thermometers for non-essential uses. Additionally, many states have enacted their own bans. Importers should verify both federal TSCA compliance and applicable state-level restrictions before attempting to import mercury-filled thermometers of any type.