Guidance on X-Ray Medical Devices for Animal Use - FDA

Kuldeep Singh

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#1
Hello everyone,

We are introducing ourself as manufacturer of X-Ray medical devices such as C-Arm machine, X-Ray machines etc. intended for human and animal use. We want to launch our veterinary product(s) in USA , which is intended for animal use only and as per guidance ‘ How FDA Regulates Animal Devices’, we come to know that 510(k), PMA or any premarket approval is not required for devices intended for animal use. We, as a manufacturer also need not to register establishment number. Please guide if i am wrong.

Can you please also guide us, as a Non-US manufacturer how can we sold our veterinary products in USA. What additional documents / registration or any approval , we must have to enter in US market.
 
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