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What is the estimated time to obtain FDA certification?
Category：行業(yè)資訊 Date：2024-08-27 16:44:23 Author: Source:
These times can vary based on factors such as the completeness of the submission and the FDA’s review process.

The estimated time to obtain FDA certification varies depending on the type of product and the specific regulatory pathway:1(2).jpg

  1. 510(k) Premarket Notification: 3 to 6 months

  2. Premarket Approval (PMA): 6 months to several years depending on complexity

  3. De Novo Classification: 6 to 12 months

  4. Registration and Listing: Days to weeks if no premarket submission is required

These times can vary based on factors such as the completeness of the submission and the FDA’s review process.

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