Hi Raza, the following FDA page offers some insight on importing medical devices for animal use, my understanding is that you need to label the device for animal use, FDA has requirements on adequate labeling, it might be helpful to start reading some of the information of the FDA from the following link:
Animal and Veterinary Products
"Veterinary device requirements verified at the time of importation.
FDA conducts label examinations of veterinary devices to ensure the labeling states "For Veterinary Use Only." For radiation-emitting veterinary devices, FDA verifies the product is registered according to the radiological health regulations.
Device manufacturers who exclusively manufacture or distribute veterinary devices are not required to register their establishments and list veterinary devices. Unlike devices intended for use in humans, pre-market approval or notification (510(k)) are not required for devices used in veterinary medicine.
It is the responsibility of the manufacturer and/or distributor of these articles to assure that these animal devices are safe, effective, and properly labeled. Visit the Compliance Policy Guidance Manual, Sec. 607.100 for more information on veterinary device labeling.
Guidance pertaining to veterinary devices may be accessed at the following FDA websites:
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Lin Wu, RAC
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Original Message:
Sent: 15-Sep-2017 08:30
From: Raza Hyder Ali Gowher Mohammed
Subject: Importing Medical Devices for Animal Use
Hello All,
Can anyone let me know the requirements for importing medical devices for animals into the US?
I know that FDA does not regulate animal medical devices, we do not need a premarket approval, no establishment registration, and no device listing. In order to import through the border, we need at least a 510k number.
Since there is no market approval, what is the best pathway to follow in order to import the devices?
Thanking you in anticipation of a favorable response
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Raza Mohammed
Regulatory Affairs Manager
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