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What are the time and costs associated with FDA certification for medical devices?
Category：行业资讯 Date：2024-08-30 17:08:45 Author: Source:
Note: These fees are subject to change annually and can vary based on specific circumstances and additional services required. Always refer to the FDA’s official website or contact the FDA for the most current information on fees and processes.

The time and costs associated with FDA certification for medical devices vary based on the type of submission and the complexity of the device. Here’s a general overview:

1. Timeframes7(1).jpg

  • 510(k) Notification:

    • Review Time: Typically 3 to 6 months from submission to decision. The exact time may vary depending on the complexity of the device and the completeness of the submission.
    • Preparation Time: Varies based on the device and the level of documentation required. Preparing a 510(k) can take several weeks to months.

  • Premarket Approval (PMA):

    • Review Time: Generally 6 to 12 months, but it can be longer depending on the device’s complexity and the need for additional information or clinical data.
    • Preparation Time: Preparing a PMA application is time-consuming and may take several months to years, especially if extensive clinical trials are required.

  • De Novo Classification:

    • Review Time: Usually 6 to 12 months. This timeframe can vary depending on the complexity of the device and the completeness of the submission.
    • Preparation Time: Similar to PMA, preparing a De Novo request can take several months to years, depending on the data and documentation needed.

2. Costs

  • 510(k) Notification:

    • Filing Fee: Approximately $14,000 (as of 2024) for standard submissions. There are reduced fees for small businesses (about $3,500).
    • Additional Costs: May include costs for testing, labeling, and consulting services.

  • Premarket Approval (PMA):

    • Filing Fee: Approximately $357,000 (as of 2024). Reduced fees apply for small businesses (about $89,250).
    • Additional Costs: Includes costs for clinical trials, testing, manufacturing, and consulting services.

  • De Novo Classification:

    • Filing Fee: Approximately $21,000 (as of 2024). Reduced fees apply for small businesses (about $5,250).
    • Additional Costs: Similar to 510(k) and PMA, additional costs may include testing, clinical trials, and consulting.

Note: These fees are subject to change annually and can vary based on specific circumstances and additional services required. Always refer to the FDA’s official website or contact the FDA for the most current information on fees and processes.

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