The fees for in vitro diagnostic (IVD) device registration in the United States vary depending on the type of submission and the device classification. The fees are set by the FDA and are subject to annual adjustments. Below are the key fees associated with IVD device registration:

1. Establishment Registration and Device Listing Fees

• Registration Fees: There is no fee for the annual establishment registration for most medical device manufacturers, including those for IVD devices.
• Device Listing Fees: Manufacturers must list their devices with the FDA. There is generally no fee for listing a device, although this can be subject to changes in regulations.

2. 510(k) Submission Fees (Premarket Notification)

• For Class II IVD devices that require a 510(k) submission, the FDA charges a fee for processing the application.
• 2024 FDA 510(k) User Fee: $19,690 (for standard submissions).
• Small Business Fee: Small businesses (defined by the FDA) are eligible for a reduced fee of $4,920.

3. Premarket Approval (PMA) Fees

• For Class III IVD devices that require Premarket Approval (PMA), the submission process is more extensive, and the fees are higher.
• 2024 FDA PMA User Fee: $449,274 (for standard submissions).
• Small Business Fee: Small businesses can apply for a reduced PMA fee of $112,318.

4. De Novo Request Fees

• If an IVD device is novel and does not have a predicate device, manufacturers may submit a De Novo request to establish a new regulatory classification. The FDA charges the following fees:
• 2024 FDA De Novo User Fee: $190,708.
• Small Business Fee: $47,677.

5. Supplemental Applications Fees

• If you need to submit a supplemental application for a change or modification to a previously cleared or approved device (e.g., a new indication, labeling, or manufacturing change), the following fees apply:
  • Supplemental 510(k) Fee: Typically the same as a standard 510(k) submission.
  • PMA Supplement Fee: Varies depending on the changes being made.

6. Annual Establishment Registration Fees for Foreign Manufacturers

• For foreign manufacturers, the FDA requires a U.S. agent for communication purposes. There is no specific fee for U.S. agents, but foreign manufacturers may incur additional costs for agent services.

7. Additional Fees

• Clinical Trial Fees: If clinical trials are required as part of a PMA submission or other clinical testing for an IVD, these costs are separate and depend on the scope of the trials.

8. Other Costs

• Consultation Fees: If a company seeks pre-submission consultations with the FDA or requests special review meetings (such as a Q-Sub meeting), additional fees may apply.
• Inspection Fees: If the FDA needs to conduct an inspection of the manufacturing facility (such as for QSR compliance), there may be additional inspection fees, depending on the nature of the inspection.

Payment Process:

• FDA fees are typically paid through the FDA's User Fee System and can be paid online via the FDA's website.
• Fees are subject to change annually based on the FDA’s budget and may vary depending on specific device characteristics.

Small Business Waivers and Reductions:

• Small businesses may qualify for fee reductions or waivers, particularly for 510(k) submissions and PMA applications, as defined by the FDA’s small business criteria.

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