FDA released final guidance on the Breakthrough Devices Program. The guidance outlines program policies, features and the process for manufacturers to follow when choosing to pursue the breakthrough designation. Eligible are medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. These and other new steps to promote innovations in medical devices are discussed in a Center for Devices and Radiological Health (CDRH) statement.
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