Office of Device Evaluation, Center for Devices and Radiological Health, US Food and Drug Administration, 10903 New Hampshire Avenue, WO 66, Room 422, Silver Spring, MD 20850, USA.
Hernia. 2011 Dec;15(6):603-5. doi: 10.1007/s10029-011-0872-3. Epub 2011 Sep 11.
The FDA's Center for Devices and Radiological Health (CDRH) is responsible for providing reasonable assurance of safety and effectiveness of all medical devices marketed within the US. To date, CDRH has cleared numerous hernia mesh devices for general use, but has not cleared/approved any mesh devices intended for certain specific uses, such as for infected wounds, hernia prevention, biofilm reduction, or prevention of adhesions. CDRH is requesting that manufacturers seeking specific hernia mesh device labeling claims consult with the Agency to determine the level of evidence necessary for justifying such claims.
美国食品和药物管理局（FDA）的设备和放射卫生中心（CDRH）负责为在美国销售的所有医疗器械提供合理的安全和有效性保证。迄今为止，CDRH 已经批准了许多疝网片设备的一般用途，但尚未批准/批准任何专门用于特定用途的网片设备，例如用于感染性伤口、疝预防、生物膜减少或预防粘连。CDRH 要求寻求特定疝网片设备标签声明的制造商与该机构协商，以确定证明此类声明所需的证据水平。
