Description
This session will provide an overview of the regulatory requirements and obligations for Humanitarian Use Devices. The session will cover specific steps necessary to gain Humanitarian Use Device status and the submission requirements for HDE approval. The session will also highlight the sponsor obligations once an HDE is granted. The session will include a discussion of the pros and cons of pursuing an HDE for a medical device.
Learning Objectives:
- Gain an understanding of the FDA regulations concerning Humanitarian Use Devices
- Learn the steps required to obtain a Humanitarian Device Exemption (HDE)
- Understand the limitations, obligations and reporting requirements for HDEs
Speaker(s):
