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EMERGO 集团完成对美国FDA批准的医疗器械510(K)申请的分析 - China Medical Device Manufacturer
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Sun, December 17th, 2017

2011年8月CMDM电子快讯 » 行业新闻
EMERGO 集团完成对美国FDA批准的医疗器械510(K)申请的分析

EMERGO集团近期完成了对美国FDA批准的510(K)申请的全面分析。二级设备和某些一级和三级产品必须提供过510(K)的审核流程,又称“上市前通知。”EMERGO的调查分析了从2006年1月1日到2010年5月23日期间,FDA批准的13,621项“上市前通知”申请。您可以从以下链接下载PDF版本报告全文。www.emergogroup.com/research

以下是报告的要点:
  • 超过53%的FDA 510(K)在三个月内获批。超过80%的内容在6个月内获批。
  • 2006年,FDA批准510(K)申请的时间平均为96天。2010年,从提出申请到获得批准的平均时间为132天,增加了37%。

EMERGO集团全球营销副总裁Chris Schorre表示,“阅读这些分析,我想提醒大家不要自动假设FDA花费更多的时间来审查510(K)“上市前通知”申请。这份报告显示,2006年以来,从生产商提交510(K)“上市前通知”申请到FDA批准的时间有大幅提升。一个可能的解释是FDA审核员要求更高比例的提交510(K)申请的生产商,出示更多的临床性能数据。这就会增加了批准审核的时间,因为生产商对FDA提出的额外要求做出反馈。

2006年到2010年的汇总数据显示,批准放射科、心血管、骨科和普通/整形外科类提交产品的时间分别为72,90,93和96天——这比调查期间的平均时间要少很多。上述四类产品类别就占提交的FDA510(K)申请的一半以上。

本报告还显示,FDA批准的510(K)申请的总数在2006年到2007年下降了10%,但从2008年开始批准数量稳定在每年3000到3100项。

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