Final answer:
Veterinary devices are regulated by the Center for Veterinary Medicine (CVM) and not by the Center for Devices and Radiological Health (CDRH), and thus are not subject to the same IDE regulations as human medical devices. They have different regulatory requirements overseen by the CVM.
Step-by-step explanation:
Devices intended solely for veterinary use are indeed regulated differently than those intended for human use. While the Center for Devices and Radiological Health (CDRH) is responsible for the approval of medical devices intended for human use, the Center for Veterinary Medicine (CVM) oversees medications and devices intended for animals.
It's important to note that the regulation of veterinary devices is not under the purview of the CDRH, and therefore they are not subject to the same Investigational Device Exemption (IDE) regulations as those devices intended for human use.
The IDE regulations are specific to medical devices for human use, which require a premarket approval to ensure safety and effectiveness. In contrast, veterinary products are primarily overseen by the CVM and may have different regulatory requirements, including risk assessments for human exposure in the case of food animals.
Veterinary products can also indirectly affect humans through environmental impact, but these aspects are also regulated primarily through the CVM, ensuring that human food supplies or the environment are not adversely affected by veterinary medicines or devices.