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How Long Does FDA Certification Take in the United States?
Category：行業(yè)資訊 Date：2024-08-21 17:25:56 Author: Source:
These timelines are general estimates and can be affected by the completeness of your submission, the need for additional information, and the FDA’s current workload.

The time required for FDA certification in the United States varies depending on the type of product and submission. Generally:7(3).jpg

  1. Medical Devices:

    • 510(k) Notification: Typically takes about 90 days for the FDA to review and decide.
    • Premarket Approval (PMA): Can take from 180 to 360 days, depending on the complexity of the device and the quality of the submission.
    • De Novo Classification: Usually takes around 120 days for the FDA to review.

  2. Drugs:

    • New Drug Application (NDA): Usually takes about 10 months for standard review and 6 months for priority review.
    • Abbreviated New Drug Application (ANDA): The review process typically takes around 10 months.

  3. Biologics:

    • Biologics License Application (BLA): Typically takes about 10 months, with an option for priority review that can shorten this time to 6 months.

  4. Food Products:

    • Generally Recognized as Safe (GRAS) Notification: The review process may take several months to a year, depending on the complexity and data provided.

These timelines are general estimates and can be affected by the completeness of your submission, the need for additional information, and the FDA’s current workload.

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