Donawa M
Med Device Technol. 2001 Apr;12(3):29-32.
For some time now, the only publicly available compliance programme guidance manual on medical device inspections and administrative and enforcement activities has been a draft document. On 7 February 2001, a final guidance document was issued. This article discusses this document and its importance to non-US medical device manufacturers preparing for FDA facility inspections.
一段时间以来，唯一公开可用的关于医疗器械检查以及行政和执法活动的合规计划指导手册一直是一份草案文件。2001年2月7日，发布了一份最终指导文件。本文讨论了该文件及其对准备接受美国食品药品监督管理局（FDA）工厂检查的非美国医疗器械制造商的重要性。
