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 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