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How many days does it take to obtain FDA certification in the USA?
Category：行業(yè)資訊 Date：2024-08-28 16:55:27 Author: Source:
In summary, while the FDA aims to review 510(k) submissions within 90 days and PMA submissions within 180 days, the actual time to obtain FDA certification can be influenced by various factors and may extend beyond these timeframes.

The time required to obtain FDA certification in the USA can vary significantly depending on the type of medical device and the specific regulatory pathway it follows. Generally, there are two primary pathways for FDA certification: the 510(k) premarket notification and the Premarket Approval (PMA) process.7(2).jpg

  1. 510(k) Premarket Notification:The 510(k) process is used for devices that are substantially equivalent to an already legally marketed device. The FDA's goal for reviewing a 510(k) submission is 90 days. However, the actual time can be longer depending on several factors:

    • Completeness of Submission: If the submission is incomplete or if the FDA requests additional information, the process can be extended.
    • Device Complexity: More complex devices may require additional time for review.
    • FDA Workload: High submission volumes can affect review times.

    On average, the entire 510(k) process, including preparation, submission, and review, can take between 3 to 6 months. In some cases, it might be longer if there are issues or additional information is needed.

  2. Premarket Approval (PMA):The PMA process is used for higher-risk devices that require more extensive clinical data. The review time for a PMA submission is generally up to 180 days, but the total time can be much longer. Factors influencing the PMA timeline include:

    • Clinical Trials: If clinical trials are needed, this can extend the timeline significantly.
    • Complexity of Device: More complex devices with novel technologies can require more time for evaluation.
    • FDA Feedback: The need for additional data or revisions can lengthen the review process.

    Overall, the PMA process can take anywhere from 1 to 2 years or more, depending on the specifics of the submission and the review process.

In summary, while the FDA aims to review 510(k) submissions within 90 days and PMA submissions within 180 days, the actual time to obtain FDA certification can be influenced by various factors and may extend beyond these timeframes.

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