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

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