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What is the timeline for the registration process of in vitro diagnostics in the United States?
Category：企業(yè)動態(tài) Date：2024-11-18 17:17:34 Author: Source:
In addition to these timelines, the entire process can be influenced by factors like the need for clinical trials, the completeness of the submitted documentation, and whether the FDA requires additional information or clarifications.

The timeline for the registration process of in vitro diagnostics (IVDs) in the United States can vary based on the device classification and the type of submission required. Here’s a general overview:

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  1. Class I Devices: Most Class I devices are exempt from premarket notification (510(k)) and only require establishment registration with the FDA. The process typically takes several weeks to a few months for establishment registration.

  2. Class II Devices (510(k)): The process for 510(k) premarket notification generally takes about 3 to 6 months. However, it can take longer if the FDA requires additional information or testing.

  3. Class III Devices (PMA): For high-risk devices, a Pre-market Approval (PMA) submission is required. The PMA process is more complex and can take 12 to 18 months or longer, depending on the complexity of the device and the FDA’s review.

  4. Emergency Use Authorization (EUA): For devices like COVID-19 diagnostic tests, the FDA may issue an Emergency Use Authorization (EUA), which can expedite the process. The timeline for an EUA varies but typically takes a few weeks to a few months.

In addition to these timelines, the entire process can be influenced by factors like the need for clinical trials, the completeness of the submitted documentation, and whether the FDA requires additional information or clarifications.

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