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"How Long Does FDA Registration and Certification Typically Take in the United States?"
Category：行業(yè)資訊 Date：2024-08-26 17:17:59 Author: Source:
These durations are approximate and can be influenced by factors such as the quality of the submission, the need for additional information, and the FDA's current workload.

The time required for FDA registration and certification can vary based on the type of submission and device:4.jpg

  1. 510(k) Clearance:

    • Typical Duration: About 90 days from submission to decision. However, this can extend if additional information or clarifications are requested.

  2. Premarket Approval (PMA):

    • Typical Duration: Approximately 180 days to over a year, depending on the complexity of the device and the review process. The review time can be longer if significant issues arise or additional data is needed.

  3. De Novo Classification:

    • Typical Duration: Around 120 days, though it may vary based on the complexity of the submission and additional information required.

  4. In Vitro Diagnostic Devices (IVDs):

    • Typical Duration: Varies widely based on the device's risk classification and complexity. It can take several months to over a year.

  5. Registration and Listing:

    • Typical Duration: Device registration and listing are generally processed within a few weeks to a few months, depending on the completeness of the submission.

These durations are approximate and can be influenced by factors such as the quality of the submission, the need for additional information, and the FDA's current workload.

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