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Frequently Asked Questions
The FDA does not “approve” animal wellness devices in the same way it approves drugs. Under FDA regulations, manufacturers that exclusively produce or distribute animal devices are not required to register with the FDA or list their products, and they are exempt from post-marketing reporting requirements.
That said, it is the responsibility of the manufacturer and/or distributor to ensure that animal devices are safe, effective, and properly labeled. We take this responsibility seriously and design our products with animal comfort, safety, and quality as top priorities.
The FDA encourages veterinarians and pet owners to report any adverse experiences or product concerns related to animal devices. If you ever experience an issue, you’re welcome to contact us directly, and you may also report concerns to the FDA using Form FDA 1932a.
More information on how the FDA regulates animal devices can be found here:
https://www.fda.gov/animal-veterinary/animal-health-literacy/how-fda-regulates-animal-devices
