FDA Regulation of Mobile Medical Apps

作者：Jeffrey Shuren, Bakul Patel, Scott Gottlieb · 发表于：JAMA · 年份：2018 · DOI：10.1001/jama.2018.8832 · 被引用次数：169 · 研究领域：Mobile Health and mHealth Applications、Biomedical Ethics and Regulation

This Viewpoint describes the FDA’s guidance on digital tools that seeks to balance technological innovation with assurances that medical mobile apps and other devices that fall within the agency’s regulatory purview are safe and effective.