五月天堂婷婷爱,色狠狠天天综合色香阁,91免费看国产,久久久久成人精品亚洲国产av综合,91啦在线播放,免费a一级毛片在线播放,天天日日夜夜看综合网,亚洲成人国产精品,奇米影视7777狠狠狠狠色,日韩精品高清在线观看,福利久久久,久久99国产精品片久久99蜜桃,91香蕉视频网址,婷婷91,久久久久久臀欲欧美日韩,少妇丰满大乳被男人揉捏视频

What is the timeline for the registration process of in vitro diagnostics in the United States?
Category：企業(yè)動(dòng)態(tài) Date：2024-11-18 17:17:34 Author: Source:
In addition to these timelines, the entire process can be influenced by factors like the need for clinical trials, the completeness of the submitted documentation, and whether the FDA requires additional information or clarifications.

The timeline for the registration process of in vitro diagnostics (IVDs) in the United States can vary based on the device classification and the type of submission required. Here’s a general overview:

4.jpg

  1. Class I Devices: Most Class I devices are exempt from premarket notification (510(k)) and only require establishment registration with the FDA. The process typically takes several weeks to a few months for establishment registration.

  2. Class II Devices (510(k)): The process for 510(k) premarket notification generally takes about 3 to 6 months. However, it can take longer if the FDA requires additional information or testing.

  3. Class III Devices (PMA): For high-risk devices, a Pre-market Approval (PMA) submission is required. The PMA process is more complex and can take 12 to 18 months or longer, depending on the complexity of the device and the FDA’s review.

  4. Emergency Use Authorization (EUA): For devices like COVID-19 diagnostic tests, the FDA may issue an Emergency Use Authorization (EUA), which can expedite the process. The timeline for an EUA varies but typically takes a few weeks to a few months.

In addition to these timelines, the entire process can be influenced by factors like the need for clinical trials, the completeness of the submitted documentation, and whether the FDA requires additional information or clarifications.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn