A RETROSPECTIVE ANALYSIS OF US FDA BREAKTHROUGH DEVICES PROGRAM: SETTING A GLOBAL REGULATORY BENCHMARK

Abstract

U.S. Food and Drug Administration (FDA) created the Breakthrough Device Program to fasten the speed of development and review of medical technology to meet terminal illness or conditions that are debilitating and irreversible. This initiative was created to ensure faster patient access to promising innovations by enabling ongoing, early-stage dialogue with the FDA and prioritizing the review of qualifying submissions. Unlike the conventional regulatory framework, which can be time-consuming and complex, the Breakthrough Devices Program focuses on identifying and resolving regulatory barriers promptly. Eligible devices may follow various approval routes such as premarket approval (PMA), 510(k) premarket notification and De Novo classification, depending up on their risk category and innovation level. This study analyses the program's performance between 2022 and 2024, using publicly available FDA data, including device classifications and approval outcomes. Only devices that obtained marketing authorization during the study window were included in the final analysis. The findings reflect the program’s success in enhancing timely access to medical innovation while maintaining safety and efficacy. Furthermore, the program is setting a precedent globally, serving as a model for other regulatory bodies aiming to balance speed and rigor in healthcare innovation.