Glossary Term
Breakthrough Device Designation
Definition
The Breakthrough Device Designation is a program by the U.S. Food and Drug Administration (FDA) designed to expedite the development, assessment, and review of medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Devices granted this designation receive prioritized guidance and review to facilitate faster patient access.
Relevance to the MedTech Industry
The Breakthrough Device Designation supports innovation in the MedTech industry by providing regulatory pathways that accelerate the time-to-market for groundbreaking technologies. It encourages the development of devices that address critical medical needs, offering benefits such as earlier FDA feedback, priority review, and the potential to impact patient outcomes sooner.
Additional Information & Related Terms
510(k) Clearance A common pathway for FDA approval that may be expedited for breakthrough devices.
Premarket Approval (PMA) A rigorous regulatory pathway often prioritized for breakthrough devices.
Unmet Medical Need A key criterion for securing Breakthrough Device Designation.
Post-Market Surveillance Ensures continued safety and efficacy of breakthrough devices in real-world use.