What if the situation is not an emergency? Can a patient with a serious illness or condition have access to an investigational device outside a study?

  •  11/4/2020 07:35 AM

Yes, FDA recognizes that there are circumstances in which an investigational device is the only option available for a patient faced with a serious or life-threatening condition (hereinafter referred to as "compassionate use").

Can a physician use an unapproved device in an emergency?

  •  11/4/2020 07:18 AM

In general, an unapproved medical device may be used only on human subjects when the device is under clinical investigation and when used by investigators participating in a clinical trial