FDA publishes draft guidance to implement the Breakthrough Devices Program.
The Breakthrough Devices Program expedites the ability to access medical devices that are needed when faced with potential life-threatening or debilitating illnesses. This white paper reviews eligibility of this program and explains how to request a designation; as well as the general principles and considerations.
Agenda
Faculty
Elizabeth Guo
Covington & Burling LLP
Elizabeth Guo is an associate in the Food Drug and Device Group with Covington & Burling LLP.
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