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What are the time and costs for obtaining FDA certification?
Category：行業(yè)資訊 Date：2024-08-09 17:27:10 Author: Source:
The FDA certification process is comprehensive and involves detailed documentation, testing, and often inspections. Planning for potential delays and unexpected costs is advisable.

The time and costs for obtaining FDA certification can vary depending on the type of product and the specific requirements. For medical devices, the process involves several steps:1(3).jpg

  1. Pre-market Submission:

    510(k) Submission: Typically takes about 3 to 6 months. Costs range from $5,000 to $12,000, depending on the complexity and whether you use a third-party reviewer.Premarket Approval (PMA): Generally takes 1 to 2 years. The fees for PMA are higher, often ranging from $75,000 to $100,000, excluding additional costs for clinical trials and other expenses.

  2. Registration and Listing:

    Devices must be registered with the FDA and listed. The annual registration fee for medical devices is approximately $5,000.

  3. Facility Inspection:

    Depending on the risk classification of your device, the FDA may conduct an inspection of your manufacturing facility. This process can add to the overall time and costs.

  4. Additional Costs:

    Costs for consulting services, clinical trials, and other regulatory requirements can further increase the overall expense.

The FDA certification process is comprehensive and involves detailed documentation, testing, and often inspections. Planning for potential delays and unexpected costs is advisable.

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