Readers of this blog will recall my earlier posts (here and here) on expanded access programs which enable physicians of patients with critical and life-threatening conditions options to treat their patients with pre-approval medicines outside of a clinical trial setting. In a similar fashion, the medical device Expanded Access Program offers a potential pathway for patients with a life-threatening condition access to an investigational device that has not yet been approved or cleared by the FDA outside of a clinical trial. When no comparable or satisfactory therapies are available, providers may use one of three modes to provide such access:

1. Emergency use – when an individual patient is in a life-threatening situation and needs immediate treatment (there are no alternative options and no time to use existing procedures to get FDA approval for the use);
2. Compassionate use – when there are no available alternative options to treat or diagnose an individual patient or a small group of patients with a serious disease or condition; or
3. Treatment Investigational Device Exemption – when the device is also being studied for the same use under an approved Investigational Device Exemption and a group of patients with a serious or immediately life-threatening disease or condition needs treatment or diagnosis.

Interested readers may learn more about the elements of device expanded access at this web page.

Text Copyright © 2019 Katrina Rogers