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Description
[DOI] [PubMed] [Google Scholar] Sivrioglu EY, Kirli S, Sipahioglu D, Gursoy B, Sarandl E
Breakthrough Device Designation is an FDA process designed to expedite the development and review of certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions
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