An Inside Look at Obtaining Breakthrough Device Designation
Written by Sean Taffler, PhD
Published:
In 2018, the United States Food and Drug Administration (FDA) established the Breakthrough Devices Program (BDP), which allows for fast-tracking the approval of certain novel devices or device-led combination products (products that are therapeutic and/or diagnostic that combine drugs, devices, or biological products.) The goal of this program is to expedite patient access to devices that provide more effective treatment or diagnosis, through a more rapid assessment and review process, while preserving the FDA’s standards of approval. This program replaces the Expedited Access Pathway (EAP) and Priority Review for medical devices programs, as the EAP did not include 510(k) applications and the priority review is now limited only to drugs, and not devices. The BDP offers device manufacturers an opportunity to work directly with the FDA through the review stage of the pre-market approval (PMA) process. Devices that are subject to PMA, 510(k), or requests for de novo designation are eligible for Breakthrough Device designation if they meet two criteria:
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