Evaluating New Ophthalmic Digital Devices for Safety and Effectiveness in the Context of Rapid Technological Development.
PMID: 31169870 ·
Zachary M Bodnar, Ronald Schuchard, David Myung, Michelle E Tarver, Mark S Blumenkranz, Natalie A Afshari, Mark S Humayun, Christie Morse, Ken Nischal, Michael X Repka, Derek Sprunger, Michael Trese, Malvina B Eydelman
Abstract
The US Food and Drug Administration's medical device regulatory pathway was initially conceived with hardware devices in mind. The emerging market for ophthalmic digital devices necessitates an evolution of this paradigm. To facilitate innovation in ophthalmic digital health with attention to safety and effectiveness. This article presents a summary of the presentations, discussions, and literature review that occurred during a joint Ophthalmic Digital Health workshop of the American Academy of
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