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Can You Provide an Overview of the General Timeline for FDA Registration and Certification?
Category：行業(yè)資訊 Date：2024-08-21 17:26:24 Author: Source:
These timelines are subject to change based on factors such as the completeness of the application, the need for additional information, and the FDA's workload. It is crucial for applicants to thoroughly prepare their submissions and promptly respond to any FDA requests to avoid delays.

The timeline for FDA registration and certification varies based on the type of product and the specific regulatory pathway. Here is a general overview:1(3).jpg

  1. Medical Devices:

    • 510(k) Notification: The FDA typically reviews 510(k) submissions within 90 days. However, if additional information is requested, it can extend the review period. Companies should prepare for potential back-and-forth communication, which could add time.
    • Premarket Approval (PMA): The PMA process is more rigorous and generally takes 180 to 360 days. This timeline can vary based on the complexity of the device and the completeness of the application. The process includes detailed reviews of clinical and non-clinical data.
    • De Novo Classification: Usually takes about 120 days. This process is for new types of devices that are not substantially equivalent to existing devices and require a new classification.

  2. Drugs:

    • New Drug Application (NDA): Standard review takes about 10 months, while priority review can shorten this to 6 months. The review process involves evaluating the safety and efficacy of the drug based on clinical trials and other data.
    • Abbreviated New Drug Application (ANDA): Generally takes around 10 months. This process is for generic drugs and involves demonstrating that the generic is equivalent to an existing approved drug.

  3. Biologics:

    • Biologics License Application (BLA): Typically reviewed within 10 months. For products that meet criteria for priority review, the timeline can be reduced to 6 months. This process evaluates the safety and effectiveness of biological products, including vaccines and blood products.

  4. Food Products:

    • Generally Recognized as Safe (GRAS) Notification: The review process may take several months to a year. GRAS notifications involve evaluating the safety of new food ingredients or substances.

These timelines are subject to change based on factors such as the completeness of the application, the need for additional information, and the FDA's workload. It is crucial for applicants to thoroughly prepare their submissions and promptly respond to any FDA requests to avoid delays.

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