Abstract
Rapid innovation and proliferation of software as a medical device have accelerated the clinical use of digital technologies across a wide array of medical conditions. Current regulatory pathways were developed for traditional (hardware) medical devices and offer a useful structure, but the evolution of digital devices requires concomitant innovation in regulatory approaches to maximize the potential benefits of these emerging technologies. A number of specific adaptations could strengthen current regulatory oversight while promoting ongoing innovation.
All Keywords
【초록키워드】 Evolution, Regulatory, Rapid, Medical conditions, proliferation, Clinical use, regulatory pathway, offer, current, approach, potential benefit, accelerated, 【제목키워드】 Health,
【초록키워드】 Evolution, Regulatory, Rapid, Medical conditions, proliferation, Clinical use, regulatory pathway, offer, current, approach, potential benefit, accelerated, 【제목키워드】 Health,