White Paper

5 Pages
  • 5 Pages

Breakthrough Devices Program: Draft Guidance to Implement 21st Century Cures


FDA publishes draft guidance to implement the Breakthrough Devices Program.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.



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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