FDA 510K 申报服务和周期（含工厂注册和合同范围内产品列名）
FDA De Novo
FDA MD 预提交（Pre-submission）申报服务和周期
FDA 2018 Shutdown Information
The FDA plays a critical public health role. Our work provides Americans with better ways to improve their health and welfare, helps families protect their children, and enables consumers to make safe and healthier choices about the products they use and the foods they feed to their families and animals. All our work is important, but only some of our work is permitted to continue during a lapse in funding. In the absence of either an FY 2018 appropriation or a Continuing Resolution for FDA, beginning on January 20, 2018 and continuing until the date of enactment of an FY 2018 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.
During the lapse period, the agency will be continuing vital activities that are critical to ensuring public health and safety in the United States, consistent with the law. 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 criminal and certain civil investigations when we believe public health is at risk, 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. Importantly, we will also continue to address existing critical public health challenges that the FDA has been working on, including the ongoing IV saline shortage that was exacerbated by the 2017 hurricanes in Puerto Rico. Mission critical surveillance for 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 2018 until an FY 2018 appropriation for the FDA is enacted. This will mean that the FDA will not be able to accept any regulatory submissions for FY 2018 that require a fee payment and that are submitted during the lapse period.
Q Q：2761773878 （昵称：OSD_trans）