A manufacturer which of the following must file an IDE before conducting a human clinical study?

The requirement for a manufacturer to file an Investigational Device Exemption (IDE) before conducting a human clinical study is primarily tied to the novelty and regulatory status of the device being studied. In the context of the options provided, the correct answer involves a custom device being studied for safety and effectiveness in support of commercial marketing.

Custom devices are those that are specifically tailored to meet the needs of an individual patient and are not mass-produced. When a manufacturer intends to use a custom device in a manner that goes beyond its original purpose or for which regulatory clearance is not established, an IDE must be filed. This requirement ensures that proper oversight is maintained regarding the safety and effectiveness data generated from the clinical study. The IDE process permits the collection of sufficient data to support future marketing applications.

In contrast, a device that was already in commercial distribution prior to May 28, 1976, and used according to its original labeling is exempt from IDE requirements because it is typically considered safe and effective based on historical use. Similarly, a device intended solely for veterinary use does not require an IDE for human clinical studies, as it does not fall under regulations governing human use. Therefore, option C is the clear choice when it comes to necessary IDE filing before engaging in human