The fees for in vitro diagnostic (IVD) device registration in the United States depend on the type of submission required and the device classification. Below are the key fees associated with IVD device registration:

1. Establishment Registration and Device Listing

• Establishment Registration Fee: There is a fee for registering the manufacturing establishment with the FDA. For fiscal year 2024, the fee is $6,506.
• Device Listing Fee: Listing each device with the FDA also incurs a fee, which is typically included as part of the establishment registration process.

2. 510(k) Premarket Notification

• The 510(k) submission fee is required for Class II devices. For fiscal year 2024, the fee is $20,412 for standard 510(k) submissions.
• Small Business Fee: If the manufacturer qualifies as a small business (annual revenue under $100 million), the fee may be reduced. For small businesses, the fee is $5,103.

3. Premarket Approval (PMA)

• PMA Application Fee: The fee for submitting a PMA application for Class III devices is significantly higher. For fiscal year 2024, the fee is $396,720 for standard submissions.
• Small Business Fee: Small businesses may receive a reduced fee for PMA submissions. For small businesses, the fee is $99,180.

4. PMA Supplement Fees

• If there are changes to a device that require a PMA supplement (e.g., significant changes to the device’s intended use or design), a fee applies. The standard fee for a PMA supplement is $198,360, while the reduced fee for small businesses is $49,590.

5. Other Fees

• User Fees for Other Submissions: Additional fees may apply for specific submissions such as De Novo requests, Emergency Use Authorizations (EUA), or Pediatric Device Applications.
• Inspection Fees: If the FDA conducts an inspection as part of the review process, there may be additional fees associated with inspections and facility assessments.

6. Annual Maintenance Fees

• In addition to the registration and submission fees, manufacturers are also required to pay annual maintenance fees for establishment registration and device listing, which are generally included in the initial payment.

Fee Exemptions

• Small Business Exemption: Small businesses with annual revenues of less than $100 million may be eligible for reduced fees for 510(k) submissions, PMA applications, and other FDA-related submissions.
• Other Exemptions: Certain device types or public health emergencies (e.g., for devices under Emergency Use Authorizations) may qualify for fee waivers or reductions.

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