FDA Medical Device Establishment Registration and Listing Fee
Below is the fee structure for US FDA Establishment Registration and Medical Device Listing, covering the necessary services to help medical device manufacturers comply with FDA requirements efficiently and affordably.
We provide fast and affordable Medical Device Establishment Registration and Listing services, backed by years of expertise in guiding small, medium, and large scale manufacturers, both domestic and international through the FDA compliance process. With our deep regulatory know-how and US Agent service exposure, we ensure a smooth service. Check out our competitive pricing below, submit the required forms, or make a direct payment to get started
Our Pricing
| # | Service | Fee (USD) |
|---|---|---|
| 1 | FDA Medical Device Establishment Registration | $100 |
| 2 | Annual US Agent Service (Mandatory for Foreign Manufacturers and Exporters Only) |
$550 |
| 3 | Medical Device Listing (Per device) | $100 |
# The FDA Establishment Registration Fee for FY 2025 is $9,280 (Payable directly to the FDA via wire transfer or credit card)
# We offer expedited service for all customers with a processing timeline of just 4 to 8 working days
| # | Service | Fee (USD) |
|---|---|---|
| 1 | GUDID Account Creation Assistance | $350 |
| 2 | UDI Device Listing | $300 per device (Up to 5 devices) $100 for each additional device beyond the initial 5 devices |
| # | Service | Fee (USD) |
|---|---|---|
| 1 | Primary / Secondary Label Review | $950 Per device (14 working days) |
| 2 | IFU / User Manual Review | $1500 per device (30 working days) |
Frequently Asked Questions
How can I start the process?
What is the Role of US Agent?
US FDA Medical Device Establishment Registration and Listing Fee applicable for Initail Importers
What is GUDID Submission?
GUDID (Global Unique Device Identifier Database) is an online database managed by the FDA. It stores key information about medical devices, such as the device name, model, manufacturer, and other identifiers. Only the Device Identifier (DI) part of the UDI is submitted to GUDID. The Production Identifier (PI) part, like lot number or expiration date, is not included in the database.
Explain the GUDID Submission Deadlines?
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Class III devices (including software): Submit by September 24, 2014
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Implantable, life-supporting, and life-sustaining devices (including software): Submit by September 24, 2015
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Class III and Class II reusable devices (UDI required on the device): Submit by September 24, 2016
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Class II reusable devices and Class I/unclassified devices (including software): Submit by September 24, 2018
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Class I reusable devices (UDI required on the device): Submit by September 24, 2020
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Class I and unclassified devices made and labeled on or after September 24, 2018: Submit by September 24, 2022
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Class I and unclassified devices made and labeled before September 24, 2018:
Submit by September 24, 2022
Who assigns the UDI for medical devices?
The FDA has accredited three Issuing Agencies. They are GS1, HIBCC, and ICCBBA to assign Unique Device Identifiers (UDI).
How can I get a UDI for my device? Is there a cost for UDI assignment?
You can contact any of the accredited Issuing Agencies (GS1, HIBCC, or ICCBBA) to obtain a UDI.
Yes, each Issuing Agency has its own fee structure, so the cost may vary depending on the agency you choose.
Which medical devices are required to have a UDI on the label? Do device packages also need a UDI?
All medical devices, including in vitro diagnostic devices (IVDs), must have a UDI on their label. However, Class I devices that are cGMP exempt do not need to be labeled with a UDI. Yes, every device package must include a UDI.
What about devices in combination products with an NDC?
Devices that are part of co-packaged combination products and bear an NDC (National Drug Code) must also have a UDI on the label.