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The registration fees for in vitro diagnostic (IVD) devices in the United States are determined by the FDA (Food and Drug Administration). The exact fees depend on the type of registration and the classification of the device.

Here is a general overview:

1. Premarket Notification (510(k)) Fees:

   • Standard Fee: For 510(k) submissions, the FDA charges a fee for most devices, except for certain types of devices and applicants (such as small businesses).
   • Fee for FY 2024: $20,712 (for standard applicants)
   • Small Business Fee: $5,178 (if the applicant qualifies for small business status)

2. Premarket Approval (PMA) Fees:

   • Standard Fee: For devices requiring PMA (class III devices), the fee is much higher.
   • Fee for FY 2024: $433,829 (for standard applicants)
   • Small Business Fee: $108,457 (if the applicant qualifies as a small business)

3. Establishment Registration and Device Listing:

   • Establishment Registration Fee: $6,782 (for both domestic and foreign establishments)
   • Device Listing: There is no additional fee for listing individual devices, but the establishment must be registered.

4. Other Fees:

   • De Novo Request: If a device is not classified and requires a De Novo request for classification, the fee is $228,300.
   • Foreign Establishment Fees: Foreign establishments must also pay additional fees for registration and listing.

These fees can be subject to annual updates based on FDA budget allocations. It is recommended to consult the FDA's official website for the most up-to-date and specific fee schedules.

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