While the HDE pathway facilitates access to important devices, it comes with limitations: - Approval for Specific Conditions: The device can only be used for the specific condition for which it was approved. - Institutional Review Board (IRB) Oversight: Each institution that uses the device must have an IRB review and approve the use of the device. - Informed Consent: Patients and their guardians must be fully informed about the device's benefits and risks.
