FDA's Breakthrough Devices Program, established in late 2016 under the 21st Century Cures Act, is beginning to show important results for patients.
Consider Second Sight Medical Products Inc.'s implant, the Orion, one of the products which qualified for the voluntary Breakthrough program intended to help patients gain timely access to devices and breakthrough technologies.
To be eligible, a technology must provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases. In addition, there must be no approved or cleared treatment, or the device must offer significant advantages over existing approved or cleared alternatives.
The Orion is a brain implant for those patients with blindness caused by damage to the optic nerve. With the designation, Second Sight, of Sylmar, Calif., qualified for interactive and timely communication with FDA, even before the company embarked on a clinical trial to study the device in patients. These early interactions resulted in the development of a flexible study design, review team support, and senior management engagement, all of which may allow a sponsor to evaluate complex, innovative technologies more efficiently.
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