How Much Is the FDA Medical Device Registration Fee in 2024?

For its fiscal year of 2024, stretching from October 1 2023 through September 30 2024, the Food and Drug Administration (FDA) medical device registration fee rates have increased from $6,493 to $7,653.

Predicting the cost of registering your medical device can be tough, as the fees change from year to year, and increases aren’t always steady. Let’s take a look at fee changes from the past decade so you can be best prepared for FY 2024 and the years to come.

How Much Is the FDA Medical Device Registration Fee in 2024?

The FDA medical device annual establisment registration fee for 2024 is $7,653.

However, there are other application fees that medical device manufacturers should be aware of when they’re working on their budgets. All fees increase year-on-year, often in line with inflation or above.

This year, a whopping 9.5% increase took place.

Who Must Register, List, and Pay the Annual Registration Fee?

The FDA publishes comprehensive guidelines here, but in general, any company that is involved in the production and distribution of medical devices that are intended to be sold commercially in the U.S. must pay the annual fee — including devices that are intended for export only.

Additionally, most companies that are required to register must also list the devices and the activities performed on those devices as outlined in Title 21 CFR Part 807.

This is different for small business fees, according to the FDA’s site. For all small business submissions, except a 30-day notice and a 513 (g) request, the fee is 25% of the standard fee. For 30-day notices and 513 (g) requests, the fee is 50% of the standard. Small business determination is based on the total amount of gross receipts and sales. If revenue is less than $100,000,000 for the previous fiscal year, then a business can be eligible. They may also be eligible for a first premarket application waiver if gross receipts and sales are no more than $30,000,000.

Plan Ahead: Approximated Annual Establishment Registration Fees

When we look back at the Annual Establishment Registration Fees in the 2010s, we can see that:

• The average increase in the fee was about 9.53%
• The highest increase during that time was 31.01%
• The biggest decrease during that time was 12.81% (decreases only happened in 2012 and 2017)

The fee will almost certainly be north of $8000 by next year - so plan accordingly.

What Is the Deadline for Registering Medical Devices with the FDA?

If you plan to register your device by September 30, 2024—the end of FY 2024—then you have to pay the FY 2024 registration fee. This fee applies to all medical devices registered between October 1 2023 and September 30 2024.

Paying the fee is only the first step in the process. Registration isn’t complete until you receive confirmation from the FDA. Give yourself time to pay the fee, as payment confirmation times can vary based on payment type:

• Electronic payments: Confirmation can be received as quickly as 24 hours
• Paper check: After receipt via mail, confirmation can take up to seven business days
• Wire transfer: This option is for foreign companies that don’t have access to credit cards or U.S. bank accounts. The FDA does not currently say how long this confirmation takes, but they note you’ll be responsible for paying all fees associated with the wire transfer.

FDA Medical Device Registration Details

If you have questions during the registration process for your medical device, the FDA provides online resources to help, but here are some of the commonly asked questions according to the FDA User Fees Help website.

What are the main steps in the registration process?

• Paying the fee on the FDA’s site
• Get your payment identification number (PIN) and payment confirmation number (PCN) from the FDA
• Log into the FDA Unified Registration and Listing System (FURLS) to either register your device or send in your annual registration

How can you get help during the registration process?

This site gives the information you need to complete your registration, but if you still need assistance, you can contact the FDA via email at reglist@cdrh.fda.gov or call them at 301-796-7400.

My PIN says it’s in “entered” status. What does that mean?

There are three status types for your PIN: entered, booked, or canceled.

• Entered means the payment has either not been made or processed
• Booked means the payment was received
• Canceled means your order was canceled; PINs can only be canceled if they’re in Entered status

Save Money by Avoiding Noncompliance Fees

You can't change the fees you have to pay the FDA, but you can save money by not paying fees for compliance problems.

You can learn from the mistakes that other companies make that result in warning letters and compliance issues. These include:

• CAPA violations that account for nearly one-third of all FDA Form 483 submissions 
• Inadequate purchasing controls that resulted in one out of six medical device manufacturers receiving FDA 483 citations last year.
• Errors in complaint procedures which are often among the most common reason for FDA 21 CFR 820 warnings 

When the FDA issues a Form 483 violation, you are responsible for fixing the issue. If you don’t, you’ll get a warning letter and could face seizure, injunction, or prosecution and fines. One way to help avoid common violations is by using a quality management system, where you can automate tasks, track manufacturing processes, and monitor your design history files all in one place.

FURTHER READING:

5 Common Medical Device Regulatory Compliance Problems

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