Fed Regist. 2018 Jun 5;83(108):25910-5.
The Food and Drug Administration (FDA or the Agency) is publishing an order to exempt a list of class II devices from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for the listed class II devices. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. FDA is also amending the codified language for the listed class II devices to reflect this final determination. FDA is publishing this order in accordance with the section of the Federal Food, Drug, and Cosmetic Act (FD&C Act) permitting the exemption of a device from the requirement to submit a 510(k).
美国食品药品监督管理局（FDA或该机构）发布一项命令，在某些限制条件下，豁免一系列二类医疗器械的上市前通知（510(k)）要求。这项在某些限制条件下的510(k)豁免，对所列的二类医疗器械立即生效。此项豁免将减轻医疗器械行业的监管负担，并消除遵守某些联邦法规所需的私人成本和支出。FDA还在修订所列二类医疗器械的编纂语言，以反映这一最终决定。FDA根据《联邦食品、药品和化妆品法案》（FD&C法案）中允许豁免器械提交510(k)要求的条款发布本命令。
