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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.

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