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What Are the Costs and Timelines for FDA Certification of Medical Devices?
Category：行业资讯 Date：2024-09-14 16:33:10 Author: Source:
Additional costs may include clinical trials, testing, and consulting fees. Timelines can be influenced by the completeness of the application and the FDA’s review process.

The costs and timelines for FDA certification of medical devices vary based on the submission type:8(2).jpg

  1. 510(k) Submission:

    • Cost: Approximately $12,000 (for standard review); may be reduced for small businesses.
    • Timeline: Typically 90 days, but can be longer if additional information is requested.

  2. Premarket Approval (PMA):

    • Cost: Approximately $365,000 (for standard review); varies with the complexity of the device.
    • Timeline: Usually 180 days, but can be extended based on the need for additional data or complex reviews.

  3. De Novo Request:

    • Cost: Approximately $13,000.
    • Timeline: Generally around 150 days, but may vary based on submission specifics.

Additional costs may include clinical trials, testing, and consulting fees. Timelines can be influenced by the completeness of the application and the FDA’s review process.

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