What does the FDA recommend for clinical use of a HUD outside its approved indications?

The FDA recommends that when a Humanitarian Use Device (HUD) is to be used outside of its approved indications, informed consent and patient protection measures must be in place. This is because HUDs are designed for use in small populations, and their application outside of approved indications can present additional risks to patients.

Informed consent ensures that patients are fully educated about the potential benefits and risks of using a HUD in a manner not originally approved, allowing them to make an autonomous choice about their treatment. This is essential in clinical practice, particularly when using devices for which the data on safety and efficacy in the unapproved context may be limited. Protective measures further ensure that patient safety is prioritized and that ethical considerations are respected in clinical practice.

While the other choices hint at related processes, they do not specifically address the requirements for patient consent and protection that are crucial when deviating from the approved indications of a HUD.