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美国FDA再次停摆!

    正当是西方的圣诞之际,在FDA官网出现《FDA Lapse in Funding》,从2018年12月22日开始,在没有2019财政年度拨款或对FDA持续决议的情况下,FDA再次出现了停摆。这说明FDA出现了财政危机,除了部分紧急、对公共卫生安全造成威胁的事宜,其它工作都已处在停滞状态。

    这已经不是FDA的第一次停摆,至目前为止,停摆时间最长的一次为21天。由于此次停摆恰逢圣诞节日,FDA工作组已停止工作,我们卓远天成也证实目前FDA审核员已经不回复邮件,不反馈,不回应。截止现在,FDA还没有正式出文说明是否会延长整改递交或是工厂审查期限,所以各企业还是应当在规定的时限内向FDA递交补充材料,并积极做准备工作。一旦FDA恢复工作,各企业能迅速做出各项决定,尽可能降低对市场准入进度的影响。

FDA官网全文:

In the absence of either an FY 2019 appropriation or a Continuing Resolution for FDA, beginning on December 22, 2018 and continuing until the date of enactment of an FY 2019 appropriation or Continuing Resolution ("lapse period"), agency operations continue to the extent permitted by law, such as activities necessary to address imminent threats to the safety of human life and activities funded by carryover user fee funds.

The FDA plays a critical public health role. Our work protects the food that families feed their children and pets and ensures the effectiveness of the medicine they need, all of which contribute to improving the health and welfare of Americans. All our work is important, but only some of our work is permitted to continue during a lapse in funding.

During the lapse period, the agency will be continuing vital activities, to the extent permitted by the law, that are critical to ensuring public health and safety in the United States. The mission critical, public health activities that will continue include, among other things: maintaining core functions to handle and respond to emergencies – such as monitoring for and quickly responding to outbreaks related to foodborne illness and the flu, supporting high-risk food and medical product recalls when products endanger consumers and patients, pursuing civil investigations when we believe public health is imminently at risk and pursuing criminal investigations, screening the food and medical products that are imported to the U.S. to protect consumers and patients from harmful products, and addressing other critical public health issues that involve imminent threats to the safety of human life. Mission critical surveillance for significant safety concerns with medical devices and other medical products will also continue.

In addition, the FDA will continue to support activities funded by carryover user fee balances, which allows us to continue to bring new therapeutic options to the patients that need them. However, during the lapse period, the FDA will not have legal authority to accept user fees assessed for FY 2019 until an FY 2019 appropriation or Continuing Resolution for the FDA is enacted. This will mean that the FDA will not be able to accept any regulatory submissions for FY 2019 that require a fee payment and that are submitted during the lapse period.


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