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What are the components of the fees for FDA registration?
Category：行業(yè)資訊 Date：2024-08-06 16:43:39 Author: Source:
The components of the fees for FDA registration typically include:

The components of the fees for FDA registration typically include:

  1. Establishment Registration Fee: This is an annual fee that medical device establishments must pay to register with the FDA.

  2. 510(k) Submission Fee: A fee for submitting a 510(k) premarket notification, which demonstrates that the device is substantially equivalent to a legally marketed device.

  3. Premarket Approval (PMA) Fee: A fee for submitting a PMA application for devices that require more rigorous evaluation due to higher risk.

  4. De Novo Classification Request Fee: A fee for requesting the classification of a novel device that is not substantially equivalent to any legally marketed device.

  5. Annual Report Fee: For companies with approved PMAs, there may be an annual report fee.

  6. Supplement Fees: Fees for supplements to PMAs or other submissions, such as changes to the device or its labeling.

  7. Other Fees: This may include fees for reclassification petitions, IDE (Investigational Device Exemption) submissions, and more.

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