Fed Regist. 1998 Feb 17;63(31):7703-5.
The Food and Drug Administration (FDA) is announcing that it has issued an order in the form of a letter to the American Society for Aesthetic Plastic Surgery (ASAPS) reclassifying the suction lipoplasty system for use in aesthetic body contouring from class III (premarket approval) to class II (special controls). The reclassification is based on information regarding the device contained in a reclassification petition submitted by ASAPS and other publicly available information. Accordingly, the order is being codified in the Code of Federal Regulations. This action is taken under the Medical Device Amendments of 1976 (the 1976 amendments) as amended by the Safe Medical Devices Act of 190 (the SMDA).
美国食品药品监督管理局（FDA）宣布，已以信函形式向美国美容整形外科学会（ASAPS）发布命令，将用于美容身体塑形的抽脂塑形系统从III类（上市前批准）重新分类为II类（特殊控制）。此次重新分类是基于ASAPS提交的重新分类申请中包含的有关该设备的信息以及其他公开可得信息。因此，该命令正在编入《联邦法规汇编》。此行动是根据经《1990年安全医疗器械法案》（SMDA）修订的《1976年医疗器械修正案》（1976年修正案）采取的。
