Fed Regist. 1999 Oct 5;64(192):53927-9.
The Food and Drug Administration (FDA) is classifying the nonresorbable gauze/sponge for external use, the hydrophilic wound dressing, the occlusive wound dressing, and the hydrogel wound dressing into class I (general controls). FDA is also exempting these devices from premarket notification procedures. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA).
美国食品药品监督管理局（FDA）正在将外用不可吸收纱布/海绵、亲水性伤口敷料、封闭性伤口敷料和水凝胶伤口敷料归类为I类（一般控制）。FDA还豁免这些器械的上市前通知程序。此行动是根据经1976年《医疗器械修正案》（1976年修正案）、1990年《安全医疗器械法案》（SMDA）和1997年《食品药品管理局现代化法案》（FDAMA）修订的《联邦食品、药品和化妆品法案》（该法案）采取的。
