ARTICLE SUMMARY:
The true impact of Breakthrough Device designation may not actually be from working more closely with FDA. Experts from Parexel/Health Advances discuss a quantitative analysis and the experiences of several device companies with the Breakthrough process, highlighting benefits beyond a smoother regulatory path. By Trisha Eustaquio, Paraxel and Darcy Krzynowek and Russ Rapaport, Health Advances.
In 2015, the FDA introduced an expedited pathway for potentially life-saving medical devices to attain approval:the Breakthrough Devices Program. Fundamentally, the program is designed to speed up the regulatory process for devices that improve the treatment or diagnosis of life-threatening conditions, so that these critical devices can reach patients quicker.In practice, this entails: 1) FDA-facilitated “sprint” discussions; 2) a Data Development Plan (DDP); 3) a Clinical Protocol Agreement; and 4) prioritized pre-submission review. However, despite these tangible actions, the regulatory process is not necessarily proceeding any faster. So, where is the value in this designation?
