In the Press
December 15, 2022

Supporting Innovation Through FDA’s Breakthrough Device Program (PM360)

Similar to the drug industry’s paradigm for Breakthrough Therapy Designation, the device industry’s opportunity to participate in the Breakthrough Devices Program can open the door to U.S. Food and Drug Administration (FDA) support for expedited product development. Since the voluntary program was authorized as part of the 21st Century Cures Act, the FDA has reported significant increases in the number of designations it has granted, exceeding 200 for the first time in Fiscal Year 2021. The top three product categories receiving the most Breakthrough Device Designations since program inception are cardiovascular, neurology, and orthopedic devices. Life Sciences associate Lauren Farruggia explains more in PM360.