Investigational Device Accountability Webinar
Time: 10:00 AM PDT | 01:00 PM EDT
Duration: 60 Minutes
Instructor: Sarah Fowler Dixon
Investigational device accountability ensures that the investigational (non-FDA approved) devices are used only as described in IRB approved protocols under the direction and management of appropriately qualified research team members.
Why Should you Attend:
Investigational device accountability is outlined in the FDA´s regulations. This webinar includes: Receipt, storage, distribution, reconciliation, return and authorized destruction of investigational devices. Many industry sponsors already have standard operating procedures outlining these policies, but, there are instances when a standard operating procedure or guideline does not exist, and those working with these devices need to know their responsibilities.
Objectives of the Presentation:
- Define investigational devices
- Review the regulations and guidance
- Discuss device accountability requirements
- Examine sample materials