中文|English
How Long Is the FDA Certification Cycle?
Category：行业资讯 Date：2024-09-14 16:32:15 Author: Source:
Overall, the timeline can be influenced by the completeness of the application, the need for additional information, and the FDA’s workload.

The FDA certification cycle duration varies depending on the type of submission:7(2).jpg

  1. 510(k) Submission: Typically 90 days, but can be longer if additional information is requested.
  2. Premarket Approval (PMA): Usually 180 days, but the process can be extended due to additional data requests or complex reviews.
  3. De Novo Request: Generally around 150 days, but it can vary based on the specifics of the submission.

Overall, the timeline can be influenced by the completeness of the application, the need for additional information, and the FDA’s workload.

Contact Us：

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


Previous： What Are the Specific Technical Standards for FDA Certification of Medical Devices?
Next： What Are the Key Points for Preparing FDA Certification Documentation and What Materials Are Required for the Application?
Back