The fees for medical device registration with the US FDA vary depending on the type of device and the submission process. The main fees involved are related to the premarket notification (510(k)), premarket approval (PMA), and establishment registration. The FDA fees are typically updated annually, and the following provides a general breakdown:

1. Establishment Registration Fee

• This is the fee for registering the manufacturing facility with the FDA. It applies to any establishment that manufactures, repacks, or distributes medical devices in the U.S.
• Fee for Fiscal Year 2024: $6,485 (subject to annual updates)

2. Device Listing Fee

• In addition to establishment registration, manufacturers must also list their devices with the FDA. The device listing fee is generally included in the establishment registration fee for domestic manufacturers.
• Fee for Fiscal Year 2024: No separate listing fee if included in establishment registration.

3. 510(k) Premarket Notification Fees

• For devices requiring a 510(k) submission (most Class II devices and some Class I devices), the FDA charges a fee for the review of the submission.
• Fee for Fiscal Year 2024:
  • Standard 510(k): $20,846
  • Small business 510(k) (defined as businesses with fewer than 50 employees and less than $100 million in gross annual sales): $5,211
• Note: The FDA allows small businesses to apply for a fee reduction under the Small Business Fee Waiver program.

4. Premarket Approval (PMA) Fees

• For Class III devices, the FDA requires a PMA submission, which is typically a more expensive and complex process than a 510(k).
• Fee for Fiscal Year 2024:
  • Standard PMA Fee: $432,268
  • Small Business PMA Fee: $108,067
• Note: Small businesses may also be eligible for a reduced PMA fee if they meet the criteria for a fee waiver.

5. Humanitarian Device Exemption (HDE) Fee

• For devices intended to treat rare conditions, the HDE submission may have a reduced fee:
• Fee for Fiscal Year 2024: $47,324

6. Other Fees

• 510(k) Substantial Equivalence Review Fee for Combination Products: Combination products (e.g., drug-device combinations) may have additional fees, depending on the review pathway.

Fee Waivers and Reductions

• The FDA offers fee waivers or fee reductions for small businesses, as mentioned above. Small businesses can apply for a fee waiver if they meet certain criteria, such as having fewer than 50 employees and gross annual revenues of less than $100 million.
• Additionally, the Humanitarian Device Exemption (HDE) pathway typically has a reduced fee structure, aimed at encouraging innovation for rare diseases.

These fees are subject to change annually, and it's important for manufacturers to consult the FDA's official website or the Federal Register for the most up-to-date fee schedules.

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