Animal Devices - Some Questions

B_Cologne

Registered
Hello Everyone,
I had a question about Animal Devices in the US. Please feel free to also consider this question for the EU. I don't really see much regulation beyond the need for appropriate product labeling if the device is specifically for animal use. I am strictly speaking about equipment or devices that do not incorporate drugs or are considered animal feed. The FDA says that "Device manufacturers who exclusively manufacture or distribute animal devices are not required to register their establishments or list animal devices with FDA and are exempt from post-marketing reporting."

My first question is: Does this mean that device manufacturers that manufacture both human and animal devices must list their animal devices as well and do pmr on those too? Or are the animal devices not required to be listed and reported on?

My second question is: I see some manufacturers of animal devices may have CE marking or claim conformance with ISO 9001. I'm talking about strictly animal devices, not a device that has been certified for use on humans and can be used on animals. And I've even seen some that fake a certification. Are there any QMS regulations and/or certifications that are required, looked for, or common in the veterinary medical device space? Again, strictly talking about devices, not feed, drugs, or drug infused.

I appreciate any guidance with this.

Thank you,

B_Cologne
 

Aliken

Involved In Discussions
Hello Everyone,
I had a question about Animal Devices in the US. Please feel free to also consider this question for the EU. I don't really see much regulation beyond the need for appropriate product labeling if the device is specifically for animal use. I am strictly speaking about equipment or devices that do not incorporate drugs or are considered animal feed. The FDA says that "Device manufacturers who exclusively manufacture or distribute animal devices are not required to register their establishments or list animal devices with FDA and are exempt from post-marketing reporting."

My first question is: Does this mean that device manufacturers that manufacture both human and animal devices must list their animal devices as well and do pmr on those too? Or are the animal devices not required to be listed and reported on?

My second question is: I see some manufacturers of animal devices may have CE marking or claim conformance with ISO 9001. I'm talking about strictly animal devices, not a device that has been certified for use on humans and can be used on animals. And I've even seen some that fake a certification. Are there any QMS regulations and/or certifications that are required, looked for, or common in the veterinary medical device space? Again, strictly talking about devices, not feed, drugs, or drug infused.

I appreciate any guidance with this.

Thank you,

B_Cologne
Hello B_Cologne,

See my post on this topic How to Regulate Veterinary Medical Devices in EU and FDA
 
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