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 FDA Registration and Certification Typically Take in the United States?"
Category：行業(yè)資訊 Date：2024-08-26 17:17:59 Author: Source:
These durations are approximate and can be influenced by factors such as the quality of the submission, the need for additional information, and the FDA's current workload.

The time required for FDA registration and certification can vary based on the type of submission and device:4.jpg

  1. 510(k) Clearance:

    • Typical Duration: About 90 days from submission to decision. However, this can extend if additional information or clarifications are requested.

  2. Premarket Approval (PMA):

    • Typical Duration: Approximately 180 days to over a year, depending on the complexity of the device and the review process. The review time can be longer if significant issues arise or additional data is needed.

  3. De Novo Classification:

    • Typical Duration: Around 120 days, though it may vary based on the complexity of the submission and additional information required.

  4. In Vitro Diagnostic Devices (IVDs):

    • Typical Duration: Varies widely based on the device's risk classification and complexity. It can take several months to over a year.

  5. Registration and Listing:

    • Typical Duration: Device registration and listing are generally processed within a few weeks to a few months, depending on the completeness of the submission.

These durations are approximate and can be influenced by factors such as the quality of the submission, the need for additional information, and the FDA's current workload.

Contact Us：

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