058  关于UDI 和笔记方向调整

整理几点最近笔记的变化

1.最近关注到研发Mark开始整理法规信息，觉得可以考虑调整下方向

2.涉及法规问题，发现guidance和官网都还没有读完，这样很被动

3.重点：关于法规，需要找个笔记本，记录最核心的内容。

4.重点：以官网和gudance 原文为主，接下来一年减少自己的解读，可以多提问。

5.提问汇总起来在最后，后续回顾的时候整理下对应的问题

6.之前的笔记都没有什么逻辑，也不方便回看，重新调整下，至少要有一个目录。

关于美国的UDI，整理对应信息如下：

1. 关于UDI的形式，其中DI 为器械识别码，是固定不变的。PI为生产识别码

2. 关于实施的日期：目前美国新出了指南对于不打算强制执行的描述截取如下

法规的长难句很难理解......

提取一下信息就是FDA does not intend to enforce 不打算执行 ，....中间的一堆产品，that are manufactured and labeled prior to September 24, 2022 在2022年9月24之前生产和贴标。

This guidance also describes the FDAs direct mark compliance policy. The FDA does not intend to enforce the direct mark requirements under 21 CFR 801.45 for finished class III, LS/LS, and class II non-sterile devices, requiring a direct mark, that are manufactured and labeled prior to their applicable direct mark compliance date, and that remain in inventory, as well as for finished class I and unclassified devices that are non-sterile, that are manufactured and labeled prior to September 24, 2022, and that remain in inventory, provided the device bears a non-UDI direct mark and the labeler has developed a method by which, using the non-UDI mark, the UDI may be made available. For more information on the policies that apply to certain devices subject to UDI direct marking, see Figure 2, below.