FDA Finalizes The Breakthrough Devices Program Guidance And Reinforces Innovative Medical Device Manufacturers That Help To Address Health Inequities

The FDA's Breakthrough Devices Program is designed to accelerate the development and approval of cutting-edge technologies for patients facing life-threatening or irreversibly debilitating diseases and conditions. This program seeks to facilitate rapid innovation by offering medical device sponsors and developers of device-led combination products the opportunity for early and frequent interaction with the FDA throughout the development process.
These interactions, coupled with priority review for premarket submissions, are intended to streamline the path to market for transformative medical solutions. The recently updated guidance underscores the FDA's dedication to working closely with sponsors, reinforcing its commitment to fostering timely innovations that address critical public health challenges and reduce health disparities. Through this program, the FDA aims to ensure that groundbreaking technologies reach patients in need as quickly and safely as possible.
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