Which device requires the filing of an IDE before human clinical study?

The requirement for an Investigational Device Exemption (IDE) is triggered primarily by the intent to study a device in human clinical trials, particularly for safety and effectiveness. A custom device being studied for these purposes falls under this regulation, as it is meant for specific patients and aims to provide clinical data about its safety and effectiveness in humans.

Devices that were in commercial distribution before May 28, 1976, which is the cutoff date for the Medical Device Amendments, are generally classified as pre-amendment devices and do not require an IDE for studies since they already have established regulatory pathways. Similarly, devices intended solely for veterinary use are not considered human medical devices and do not require compliance with IDE regulations that apply to human subjects. Thus, the focus on human clinical investigations aligns specifically with the need for an IDE when studying a custom device for safety and effectiveness in human populations.