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What Is the Typical Processing Time for FDA Registration and Certification in the United States?
Category：行業(yè)資訊 Date：2024-08-21 17:26:55 Author: Source:
The typical processing time for FDA registration and certification varies by product type and the specific regulatory pathway involved:

The typical processing time for FDA registration and certification varies by product type and the specific regulatory pathway involved:7(2).jpg

  1. Medical Devices:

    • 510(k) Notification: The FDA generally reviews 510(k) submissions within 90 days. However, if additional information is requested or if there are issues with the submission, the process can be extended.
    • Premarket Approval (PMA): This process usually takes between 180 and 360 days. The timeline depends on the complexity of the device and the thoroughness of the submission. The review involves evaluating clinical and non-clinical data.
    • De Novo Classification: Typically, this review takes around 120 days. This pathway is used for novel devices that are not equivalent to existing ones and require a new classification.

  2. Drugs:

    • New Drug Application (NDA): The standard review period is approximately 10 months. If the drug qualifies for priority review, this can be reduced to 6 months. The review assesses the drug’s safety and efficacy based on clinical trials and other data.
    • Abbreviated New Drug Application (ANDA): For generic drugs, the review process generally takes around 10 months. The focus is on demonstrating that the generic drug is equivalent to an existing approved drug.

  3. Biologics:

    • Biologics License Application (BLA): The FDA usually reviews BLAs within 10 months. Priority review can expedite this to about 6 months. The process evaluates the safety and effectiveness of biological products, such as vaccines and blood products.

  4. Food Products:

    • Generally Recognized as Safe (GRAS) Notification: The review process for GRAS notifications can vary widely but often takes several months to a year. It involves assessing the safety of new food ingredients or substances.

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