中文|English
How long does the FDA certification process typically take?
Category：行业资讯 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


Previous： What documents are essential for the FDA certification application for medical devices?
Next： How do I start the application process for FDA certification for medical devices in the United States?
Back