2013年9月25日(ri)，FDA頒布了移(yi)(yi)動(dong)醫(yi)療應用的(de)(de)正式導則，針對(dui)日益廣泛應用在醫(yi)療器械和移(yi)(yi)動(dong)互聯網和終端設備上的(de)(de)軟體(Mobile Apps)，硬件等(deng)提出了建(jian)設性(xing)意見和(he)指南。并將監管重點放在用于維持(chi)人(ren)體(ti)生命等(deng)高風險的器械上(shang)；FDA將(jiang)不斷改進和增加新的監管要求。
FDA will focus its oversight on medical mobile apps that meet the definition of device in the Federal Food, Drug, and Cosmetic Act and are intended to:
- transform a mobile device into a medical device regulated by FDA; or
- be used as an accessory to a medical device regulated by the FDA.
FDA intends to exercise enforcement discretion for other mobile apps. This focuses FDA's regulatory priorities on the small subset of mobile medical apps that could present a greater risk to health.
詳細信息請訪問FDA在線：
FDA 移動醫療應用正式導則頒布：
Mobile Medical Applications
FDA移動醫療應用相關法規和指南：
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