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最新!必读!FDA已暂停与新冠疫请无关的IVD Q-submission审核

2021-07-14 18:42 ?阅读数:1520 标签:

为应对当前由新型冠状病毒(SARS-CoV-2)及其引起的相关疾病(COVID-19)引起的疫情,美国卫生和公众服务部于2020年1月31日宣布了与COVID-19相关的公共卫生紧急状态,总统于2020年3月13日宣布美国进入紧急状态。


此后,即使在增加了额外的工作人员来支撑新冠肺炎相关工作的情况下,美国FDA仍一直处于超负荷工作状态。目前FDA下属的CDRH部门已收到6000多个pre-EUA和EUA请求,工作量大大增加。


为了应对COVID-19疫情带来的巨大工作量,保证FDA能够处理应对疫情急需医疗器械的申请,FDA已开始暂停对一些上市前申请(例如510(k)、PMA、De Novo)的审查。但已经被受理的申请会继续进行审核。


除此之外,FDA将不会接受IVD相关的Q-submission,除非该Q-submission符合以下任一条件:

●COVID-19相关

●伴随诊断相关

●突破性器械指定要求相关

●该产品对公共健康有重大影响



FDA表示,这种情况将持续到2021年底。



FDA回复英文原文如下:

In response to the current pandemic caused by a novel coronavirus (SARS-CoV-2) and the associated disease it causes (COVID-19), HHS declared a public health emergency related to COVID-19 on January 31, 2020, and the President declared a national emergency on March 13, 2020. During this time, FDA has been working along with other federal, state, and local agencies and public health officials across the country to help protect public health and address this COVID-19 pandemic. 


Due to this current national emergency, FDA has had to allocate resources to COVID-19 related activities, especially for diagnostic tests.  CDRH has received more than 6000 pre-Emergency Use Authorization (pre-EUA) and EUA requests and this has led to a significantly increased workload in the Division of Chemistry and Toxicology Devices.  To address this unprecedented pandemic IVD workload and enable FDA to address device submissions most needed to combat the pandemic, we have had to pause review of some premarket submissions (e.g., 510(k)s, PMAs, De Novos) even with bringing in additional staff to support COVID-related work.  With the limited resources available, we believe it is most important to proceed with review of premarket marketing submissions including the premarket submissions received awaiting review. To accomplish this, however, we are unfortunately unable to review every Q-submission received. At this time, we are unable to review IVD-related Q-submissions unless they are related to COVID-19, companion diagnostics, a breakthrough device designation request, or have a significant public health impact.




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