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What Is the Approval Timeline for FDA Certification in the United States?
Category：行业资讯 Date：2024-08-26 17:18:34 Author: Source:
These timelines are approximate and can be influenced by factors such as the submission’s quality, additional data requests, and FDA review priorities.

The approval timeline for FDA certification varies depending on the type of submission:7.jpg

  1. 510(k) Clearance:

    • Typical Timeline: Approximately 90 days. This can be extended if additional information or clarifications are required.

  2. Premarket Approval (PMA):

    • Typical Timeline: Around 180 days to over a year, depending on the complexity of the device and the review process. Extensions may occur if additional data or significant issues arise.

  3. De Novo Classification:

    • Typical Timeline: About 120 days, though this can vary based on the complexity of the device and the information provided.

  4. In Vitro Diagnostic Devices (IVDs):

    • Typical Timeline: Can range from several months to over a year, depending on the risk classification and the complexity of the device.

  5. Registration and Listing:

    • Typical Timeline: Generally processed within a few weeks to a few months, depending on submission completeness and the FDA's workload.

These timelines are approximate and can be influenced by factors such as the submission’s quality, additional data requests, and FDA review priorities.


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