[G/TBT/N/USA/1643]

中文标题：

物理医学设备;无创骨生长刺激剂的重新分类

英文标题：

Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators (9 page(s), in English)

成员国：美国

通报日期：2020-09-14

内容概述：

Proposed amendment; proposed order; request for comments - The Food and Drug Administration (FDA) is proposing to reclassify non-invasive bone growth stimulators, postamendments class III devices (product codes LOF and LPQ), into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification with the name "non-invasive bone growth stimulators" along with the proposed special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of these devices. FDA is proposing this reclassification on its own initiative. If finalized, this order will reclassify these devices from class III (premarket approval) to class II (special controls) and reduce the regulatory burdens associated with these devices, as these devices will no longer be required to submit a premarket approval application (PMA), but are subject to premarket notification (510(k)) requirements and general and special controls.