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What is the typical duration of the FDA registration and certification process?
Category：行業(yè)資訊 Date：2024-08-20 16:49:49 Author: Source:
In summary, while the FDA strives to adhere to these timelines, actual review durations can vary based on several factors.

The duration of the FDA registration and certification process can vary depending on the type of product and complexity of the submission. Here’s a breakdown of typical timelines:7(1).jpg

1. Medical Devices

  • 510(k) Notification: The FDA aims to complete the review of most 510(k) submissions within 90 days. However, this timeline can be extended if the FDA requests additional information or if the submission is particularly complex.

  • Premarket Approval (PMA): For Class III devices, the PMA process generally takes around 180 days. In practice, it can extend to a year or more, depending on the complexity of the device and the completeness of the application.

2. Drugs

  • New Drug Application (NDA): The standard review time for NDAs is approximately 10 months from the date of filing. For applications designated as priority reviews, the review period is shortened to about 6 months. Actual review times may vary if the FDA requires additional information or if there are significant issues with the application.

  • Abbreviated New Drug Application (ANDA): For generic drugs, the review process typically takes around 10 months. This period can be extended based on the specifics of the application and the FDA’s workload.

3. Biologics

  • Biologics License Application (BLA): The standard review timeline for BLAs is about 10 months, similar to NDAs. For priority reviews, this period is reduced to approximately 6 months. The review time may be extended if further information is needed.

4. Food and Dietary Supplements

  • Food Facility Registration: This process is usually completed within a few days to a few weeks, as it primarily involves registration rather than a comprehensive review.

  • Dietary Supplement New Ingredient Notification: Review times for these notifications typically take up to 75 days, although this can vary based on the specifics of the submission.

Factors Affecting Review Duration

  • Completeness of the Application: Incomplete or incorrect submissions can lead to delays as additional information may be required.

  • Complexity of the Product: More complex products, such as new drugs or high-risk devices, often require longer review times.

  • FDA Workload: The volume of applications and available resources at the FDA can impact review times, with high workloads potentially causing delays.

In summary, while the FDA strives to adhere to these timelines, actual review durations can vary based on several factors.

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