20140917 ECA新闻：FDA对医疗器械警告信进行分析(Julia翻译）

巴西木

GMP News
17/09/2014

FDA analyses Warning Letters with regard to Medical Devices

FDA对医疗器械警告信进行分析

The ECA annually provides an analysis of the Warning Letters issued by the FDA with regard to medical devices. The analysis is based on the Warning Letters published over a fiscal year (from 1st October to 30 September). The FDA has published its own 2012 calendar year overview.  

ECA每年都会提供一份对FDA关于医疗器械的警告信的分析。该分析是根据各财年公布的警告信所做的（从10月1日至9月30日）。FDA
刚公布了其自己对2012自然年所做的回顾。

Interestingly, the FDA says that it has made the results available for the industry to:

有意思的是，FDA说该回顾使得行业可以获得以下机会：

• Improve the quality of medical devices
• 提高医疗器械的质量
• Identify potential critical areas of manufacturers of medical devices
• 识别医疗器械生产商的潜在关键领域
• Help companies avoid the reception of Warning Letters
• 帮助公司避免收到警告信
  

In 2012 the number of domestic routine FDA inspections at manufacturers of medical devices increased by 37%. For foreign companies it was a 93% increase.

在2012年，FDA所执行的本土医疗器械生产商检查数量增加了37%，对国外公司的检查数量则增加了93%。

In respectively 30% of the Forms 483 with inspection deficiencies, the CAPA system and insufficient production and process controls (incl. the process validation topic) have been criticised. Beside CAPA failures, the most frequent deficiencies observed in the FDA Forms 483 were "Complaint-Handling" (21 CFR 820.198a) and quality audits (21 CFR 820.22). Moreover, a significant increase with regard to "device history records" (21 CFR 820.184) was recorded in the Forms 483.

在FDA检查缺陷483表中，CAPA体系和生产及工艺控制不充分的缺陷各占了30%。除了CAPA方面的问题，FDA的483表中最常见的缺陷是“客诉投诉”（21 CFR 820.198a）和质量审计（21CFR 820.22）。另外，483表中“仪器历史记录”（21 CFR 820.198a）方面的缺陷有大幅增加。

According to the FDA, the number of Warning Letters (which are significantly more serious than a Form 483) has been increasing over the last 2 years because of the growing number of inspections. Consistent with the results of the Form 483, most of the deficiencies observed in the Warning Letters also concerned CAPA and "Complaint-Handling" topics. It is noticeable that two deficiencies are much more frequent in the Warning Letters than in the inspection results: these are deviations with regard to "device history records" (21 CFR 820.184) and process validation (21 CFR 820.75a).

根据FDA的数据，由于检查次数增加，在过去2年警告信（警告信比483表要严重的多）增加了。与483表的数量相称，大部分在警告信中出现的缺陷也是关于CAPA和“客诉-处理”问题的。值得注意的是两类缺陷在警告信中出现的频次高于检查的结果：与器具历史记录的缺失有关的偏差和工艺评估（21CFR 820.75a）。

Conclusion: The result coincides pretty well with the 2012 fiscal year evaluation by the ECA. The evaluation prepared by the ECA for 2012 refers to the fiscal year while the FDA used the calendar year for their evaluation. This explains the slight differences in the results.

结论：结果与2012财处ECA所做的评估符合性很好。由ECA在2012年所做的评估是按财年统计的，而FDA使用的是自然年数据进行评估。这也就解释了为什么两者间有轻微的差异。

Please find more details in an FDA presentation.
更多信息参见FDA介绍。

PS: All delegates of the ECA Education Course "GMP for Medical Devices" from 1-2 October 2014 in Heidelberg, Germany, will receive the FDA Medical Device Warning Letter Navigator on CD-ROM with the new Warning Letter results for the fiscal year 2014.

另：所有参加2014年10月1-2日在德国海德堡举办的ECA教育课程“医疗器械GMP”的代表都会收到一份CD-ROM刻录的2014年FDA医疗器械警告信导航。

幻影

In 2012 the number of domestic routine FDA inspections at manufacturers of medical devices increased by 37%. For foreign companies it was a 93% increase.

resuper114

我觉得这个是好事情！

yang_2113963A

谢谢分享！