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What Is the Application Cycle for FDA Certification in the United States?
Category：行業(yè)資訊 Date：2024-08-21 17:29:21 Author: Source:
These cycles are general estimates and can be influenced by factors such as submission quality, additional information requests, and the FDA’s current workload.

The application cycle for FDA certification in the United States varies depending on the type of product and regulatory pathway. Here is a general overview:4.jpg

  1. Medical Devices:

    • 510(k) Notification: The application cycle typically involves about 90 days for the FDA to review and respond. However, if additional information is needed or if there are issues with the submission, the process can extend. Overall, from preparation to final approval, the cycle usually spans 3 to 6 months.
    • Premarket Approval (PMA): This process generally takes between 180 and 360 days for the FDA to review. The entire application cycle, including preparation and potential follow-up interactions with the FDA, can extend up to a year or more.
    • De Novo Classification: The review period is typically around 120 days. The overall cycle may be longer depending on the complexity of the device and additional information requests.

  2. Drugs:

    • New Drug Application (NDA): The standard review cycle is approximately 10 months, with priority review shortening this to about 6 months. The total application cycle from submission to approval can range from 6 to 12 months.
    • Abbreviated New Drug Application (ANDA): The review cycle generally takes about 10 months. This period may vary based on the completeness of the submission and any additional information requested by the FDA.

  3. Biologics:

    • Biologics License Application (BLA): The review cycle is typically about 10 months, with priority review potentially reducing this to around 6 months. The entire application cycle, including preparation and FDA communications, might span 6 to 12 months.

  4. Food Products:

    • Generally Recognized as Safe (GRAS) Notification: The review cycle can vary widely, often taking several months to a year, depending on the complexity and completeness of the safety data provided.

These cycles are general estimates and can be influenced by factors such as submission quality, additional information requests, and the FDA’s current workload.

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