高清不卡日本v二区在线,天天综合网天天综合,激情丁香五月天婷婷水蜜桃视频,91精品免费久久久久久久久,手机看片久久久久久久久,日日夜夜嫩草,日本不卡 在线视频,欧美亚洲日韩,高潮歹无毛免费观看视频,天天综合网7799日日夜夜永,欧美日本国产日韩激情视频 ,久久久无码精品亚洲日韩蜜桃,日夜夜天天人人综合网,91蜜桃长长久久,国产精品精品一区在线发布,一级a毛片免费观看久久精品

How long does the FDA certification process typically take?
Category：行業(yè)資訊 Date：2024-10-28 17:12:32 Author: Source:
Overall, it's important to plan for potential delays and additional time for preparing documentation and responding to FDA inquiries.

The duration of the FDA certification process can vary significantly based on several factors, including the type of device and the submission pathway. Here are some general timelines:1(1).jpg

  1. 510(k) Submissions: The review process typically takes about 3 to 6 months, but it can be longer if the FDA requests additional information.

  2. PMA (Premarket Approval): The PMA process is more rigorous and can take 6 months to over a year, depending on the complexity of the device and the data required.

  3. De Novo Classification: This process can take about 6 months to a year, depending on the submission details and any additional information needed by the FDA.

  4. Supplemental Applications: For changes to previously approved devices, the review can take several months.

Overall, it's important to plan for potential delays and additional time for preparing documentation and responding to FDA inquiries.

Contact Us：

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