Fed Regist. 2017 Dec 27;82(247):61170-1.
The Food and Drug Administration (FDA or we) is classifying the rectal balloon for prostate immobilization into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the rectal balloon for prostate immobilization's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
美国食品药品监督管理局（FDA或我们）正在将用于前列腺固定的直肠球囊归类为II类（特殊控制）。适用于该器械类型的特殊控制措施在本指令中予以明确，将成为用于前列腺固定的直肠球囊归类的编纂语言的一部分。我们采取这一行动是因为我们已确定将该器械归类为II类（特殊控制）将为该器械的安全性和有效性提供合理保证。我们相信这一行动还将在一定程度上减轻监管负担，从而增加患者获得有益创新器械的机会。
