What is the responsibility of clinicians using a HUD in their practice?

Clinicians utilizing a Humanitarian Use Device (HUD) have a critical responsibility to submit reports of their device use to the holder of the Humanitarian Device Exemption (HDE). This obligation is essential because it ensures that the gather data regarding the device's safety and effectiveness can be systematically collected and analyzed over time. By providing feedback on patient outcomes and device performance, clinicians contribute to a broader understanding of the device's impact in a real-world setting, which can inform future updates and regulatory decisions regarding the HUD.

The reporting helps maintain the safety and efficacy of the device in clinical practice, and fulfills regulatory requirements associated with the HDE approval process. Through this data submission, clinicians play a vital role in supporting the ongoing evaluation of devices that are designed for treatment of rare diseases or conditions, ensuring that they are being used appropriately and effectively.