The HDE process involves several steps: 1. Pre-submission Meeting: Manufacturers are encouraged to meet with the FDA to discuss their device and the HDE process. 2. Submission of HDE Application: The manufacturer submits an application that includes clinical data, non-clinical data, and a risk-benefit analysis. 3. FDA Review: The FDA reviews the application, focusing on the safety and probable benefit of the device. 4. Approval: If the FDA determines that the device meets the criteria, it grants an HDE. This allows the device to be marketed and used for the specified rare condition.
