国产一区一二区高清不卡,国产一区二区最新免费视频,51日日夜夜精品视频,日日夜夜精品视频天天7799,五月伊人国语,国产一区视频,7777无码少妇一区二区三区,五月伊人国语,7799精彩视频天天看网站,国产精品无码久久久久av,永久入口,91成品人网页进入入口,欧美 日韩 中文字幕 高清,妖精视频一区二区三区亚洲,精品亚洲永久免费精品导航,久久久国产一区二区三区,天天中文综合

How long does it take to obtain FDA registration and certification in the United States?
Category：行業(yè)資訊 Date：2024-08-27 16:42:44 Author: Source:
These are general timelines, and the actual time can vary based on the specifics of the device and the completeness of the application.

The time it takes to obtain FDA registration and certification in the United States can vary depending on the type of medical device and the specific FDA pathway it must follow. Here are some general timelines:7(4).jpg

  1. 510(k) Premarket Notification: This process typically takes 3 to 6 months from submission to clearance, assuming there are no significant issues or requests for additional information from the FDA.

  2. Premarket Approval (PMA): For high-risk devices, the PMA process can take 6 months to several years, depending on the complexity of the device and the need for clinical data.

  3. De Novo Classification Request: This pathway is for devices that are low to moderate risk but do not have a suitable predicate device. The process usually takes 6 to 12 months.

  4. Registration and Listing: If no premarket submission is required, registration and listing can be completed in a matter of days to weeks.

These are general timelines, and the actual time can vary based on the specifics of the device and the completeness of the application.

Contact Us：

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