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What is the approval timeline for FDA certification?
Category：行業(yè)資訊 Date：2024-08-22 16:51:19 Author: Source:
These timelines can vary based on the complexity of the device, the completeness of the submission, and the FDA’s current workload.

The approval timeline for FDA certification varies based on the type of submission:7(1).jpg

  1. 510(k) Premarket Notification:

    • Typical Timeline: Approximately 90 days. The FDA reviews the submission to determine if the device is substantially equivalent to a predicate device.

  2. Premarket Approval (PMA):

    • Typical Timeline: Several months to over a year. The process involves a more comprehensive review, including clinical trial data, and may require additional time for FDA evaluation and potential advisory committee reviews.

  3. De Novo Classification Request:

    • Typical Timeline: Around 6 to 12 months. The FDA reviews the request to establish a new device classification and may involve a more detailed review process.

  4. Device Listing:

    • Typical Timeline: Immediate to a few weeks. Device listing is generally processed quickly once the registration is completed.

These timelines can vary based on the complexity of the device, the completeness of the submission, and the FDA’s current workload.

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