电子体温计将被FDA列入豁免名单

  近日，美国联邦公报发布一则征求意见Medical Devices; Exemptions From Premarket Notification: Class II Devices; Clinical Electronic Thermometers; Request for Comments，对电子体温计（无远程热成像功能及连续测温功能）拟免除部分的临床上市前通知要求，即常说的510(k)豁免。那些拟被列入510(k)豁免名单的普通电子体温计产品代码是FLL。公告同时指出，将会为含远程热成像或连续测温功能的电子体温计创建新的产品代码。

相关原文：The Food and Drug Administration (FDA or the Agency) has identified certain class II clinical electronic thermometers that, when finalized, will be exempt from premarket notification requirements, subject to certain limitations. FDA is publishing this notice of that determination and requesting public comment in accordance with the procedures established by the 21st Century Cures Act. FDA will review any comments submitted within the 60-day comment period and will consider whether any modifications should be made to the exemption for certain clinical electronic thermometers prior to publication of its final determination in the Federal Register .

该通知征求意见的时间截止2024年1月2日。如最终正式生效的话，意味着想将普通电子体温计进入美国市场销售只需进行注册列名即可。