FDA Issues Guidance for New Breakthrough Devices Program
The FDA released draft guidance on a new program aimed at expediting access to breakthrough medical devices.
The program will replace the agency’s Expedited Access Pathway and Priority Review Program, adding elements of the agency’s Innovation Pathway. The new program was established by the 21st Century Cures Act to help speed development and review of certain medical devices to ensure timely patient access.
The draft guidance describes the process for seeking a breakthrough device designation and includes a template device firms can use to submit a request. It also includes the criteria agency staff will use to evaluate applications, and discusses how the agency will go about reviewing devices granted breakthrough designations.